NJ Bio, Inc._Careers

Careers

World ADC Best Contract Research Provider 2023

NJ Bio, Inc. is a rapidly growing quality CRO/ CDMO located In Princeton, NJ that provides chemistry and biopharmaceutical services specializing in bioconjugation, custom synthesis, bioassays, and process development. NJ Bio offers a competitive compensation and benefits package including 401(k), health, vision, dental, and life insurance plans.

NJ Bio is constantly expanding its team and is looking for dedicated and talented individuals.  We currently have the following job openings:

R&D - Bioconjugation

Bioassay Scientist/ Senior Scientist

Job Summary

NJ Bio is looking for a BioAssay Scientist/ Senior Scientist that is highly skilled, self-driven and professional to independently plan project responsibilities and execute workflows towards a timeline focusing primarily on in vitro characterization, assay development, and screening of targeted protein degraders. She/he will work with bioengineering group to express, purify, and characterize proteins of interest in both bacterial and mammalian cell cultures. She/he will plan and execute short-term and long-term goals; contribute to scientific discussions; stay abreast of current literature in this scientific area, prepare project reports and presentations for research updates, check and maintain up to date lab notebook, maintain equipment, inventory, and provide lab support as required.

Job Responsibilities

  • Work towards the development of in vitro assays for the screening and in vitro pharmacology/mechanism of action studies for targeted protein degrader molecules.
  • Assist bioengineering group with the bacterial/mammalian expression, isolation, purification, and characterization of proteins of interest.
  • Execute routine characterization and mechanism of action assays for targeted protein degraders in cell based and cell free assay systems.
  • Develop, optimize and monitor assay performance, ensuring reproducibility and reliability of data.
  • Provide expertise and guidance to clients, project teams and senior management.
  • Get regular updates from project group and ensure quality and project timelines are being met.
  • Check and maintain up to date lab notebooks for team on projects.
  • Prepare and present project status and progress updates to clients.
  • Contribute to scientific discussions.
  • Stay abreast of current literature in scientific areas.
  • Write project reports containing procedures and experimental details for clients.
  • Maintain equipment, chemical inventory, and lab support.
  • Perform various duties as required.
  • Other duties as assigned.


Required Knowledge, Skills, and Abilities

  • Hands on experience with bacterial and mammalian cell culture.
  • Experience with cellular assays to assess protein degradation, signaling pathways, and cytotoxicity.
  • Experience in screening, molecule characterization and in vitro pharmacology assays for targeted protein degraders.
  • Ability to effectively plan and execute multiple projects simultaneously.
  • Ability to effectively plan the work of others.
  • Ability to mentor others.
  • Ability to be an individual contributor.
  • Ability to perform with minimal supervision.
  • Ability to work collaboratively as part of a team.
  • Ability to communicate effectively, orally, in writing, and to listen actively.
  • Ability to apply critical thinking and good problem-solving skills.
  • Ability to demonstrate a willingness to learn.

The following are a plus:

  • Experience with Flow Cytometry
  • Experience with evaluating targeted protein degraders (protacs) via in vitro assays.
  • Experience with automated liquid handling instrumentation (i.e. epimotion).


Job Specifications

Education and Experience Requirements

  • Senior Scientist- Ph.D. in Biochemistry, Cell and Molecular Biology or similar field with 2-5 years industry experience or B.S. in Biochemistry, Cell and Molecular Biology or similar field with 5-7 years of experience.
  • Scientist- Ph.D. in Biochemistry, Cell and Molecular Biology or similar field with 0-2 years industry experience or B.S. in Biochemistry, Cell and Molecular Biology or similar field with 3-5 years of experience.

Working Conditions

  • 80% Laboratory work and 20% Office environment.

Certificates & Licenses Required

  • N/A

 

Confirm Job Qualifier To Apply

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


Principal Scientist- Bioconjugation

Job Summary

Lead and manage a small team of scientist. Independently plan project responsibilities; plan work for each project and execute it towards a timeline while maintaining productivity; prepare and present project status and progress updates to clients; provide input on equipment purchases; get regular updates from project group; contribute to scientific discussions; check and maintain up to date lab notebooks for team on projects; supervise Scientists, Sr. Scientists, Associate and Sr. Associate Scientists; maintain performance management metrics for personnel; be a subject matter expert for clients and stay abreast of current literature in scientific areas; write project reports containing procedures and experimental details for clients; maintain equipment, chemical inventory and participate in lab support activities.

Job Responsibilities

  • Independently plan work for each project and execute it towards a timeline while maintaining productivity.
  • Plan project execution with starting material quantities and liaise with purchase to follow up on arrivals and help procurement with selection of materials.
  • Provide input on equipment purchases.
  • Supervise Scientists, Sr. Scientists, Associate and Sr. Associate Scientists; maintain performance management metrics for personnel.
  • Be a subject matter expert for clients and stay abreast of current literature in scientific area.
  • Get regular updates from project group and ensure quality and project timelines are being met.
  • Check and maintain up to date lab notebooks for team on projects.
  • Prepare and present project status and progress updates to clients.
  • Contribute to scientific discussions.
  • Stay abreast of current literature in scientific areas.
  • Write project reports containing procedures and experimental details for clients.
  • Maintain equipment, chemical inventory, and participate in lab support activities.


Required Knowledge, Skills, and Abilities

  • Ability to effectively plan and execute projects.
  • Ability to effectively plan the work of others.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to supervisor and mentor others.
  • Ability to be an individual contributor.
  • Ability to perform with minimal supervision.
  • Ability to work collaboratively as part of a team.
  • Ability to communicate effectively, orally, in writing and to listen actively with internal and external stakeholders.
  • Ability to apply critical thinking and good problem-solving skills.
  • Ability to demonstrate a willingness to learn.


Job Specifications

Education and Experience Requirements

Ph.D. in biochemistry, protein chemistry or other related field with over 5 years industry experience or M.S. in biochemistry, protein chemistry or other related field with 10 plus years’ experience.

Physical Demands

N/A

Working Conditions

Laboratory (majority of time will be spent in lab working on ongoing projects)
Office environment

Certificates & Licenses Required

N/A

 

Confirm Job Qualifier To Apply

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


Director- Biology and Bioconjugation

Job Summary

The Director Biology and Bioconjugation is responsible for leading the bioconjugate and bioassay groups at NJ Bio. With a specific focus on Antibody Drug Conjugates (ADCs). In this role, you will play a crucial part in advancing cutting-edge therapies that combine the precision of antibodies with the potency of small molecules.

Plan project responsibilities; plan work for each project and execute it towards a timeline while maintaining productivity; plan project execution with starting material quantities and liaise with purchase to follow up on arrivals and help procurement with selection of materials; prepare and present project status and progress updates to clients; provide input on equipment purchases; get regular updates from project group; contribute to scientific discussions; check and maintain up to date lab notebooks for subordinates; supervise Scientists in the Bioconjugation department and Bioassay; maintain performance management metrics for personnel; be a subject matter expert for clients and stay abreast of current literature in scientific areas; write project reports containing procedures and experimental details for clients; maintain equipment, chemical inventory and participate in lab support activities. Perform other duties as required.

Additionally, will represent the company for business development, advise clients on solutions and instituting research plans for bioconjugate development.  Be able to implement and allow implementation of new technologies.

The Director ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Manages, coaches, and mentors direct reports.

Job Responsibilities

  • Plan work for each project and execute it towards a timeline while maintaining productivity.
  • Plan project execution with starting material quantities and liaise with purchase to follow up on arrivals and help procurement with selection of materials.
  • Provide input on equipment purchases.
  • Supervise and train subordinates; maintain performance management metrics for personnel.
  • Assist with non-assigned projects as needed.
  • Be a subject matter expert for clients and stay abreast of current literature in the scientific area.
  • Obtain regular updates from project group and ensure quality and project timelines are being met.
  • Check and maintain up to date lab notebooks for all subordinates.
  • Prepare and present project status and progress updates to clients.
  • Contribute to scientific discussions.
  • Stay abreast of current literature in scientific areas.
  • Write project reports containing procedures and experimental details for clients.
  • Maintain equipment, chemical inventory, and participate in lab support activities.
  • Complete mandatory assigned training.


Required Knowledge, Skills, and Abilities

  • Ability to effectively plan and execute projects.
  • Ability to effectively plan the work of others.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to work collaboratively as part of a team.
  • Ability to communicate effectively, orally, in writing and to listen actively with internal and external stakeholders.
  • Ability to apply critical thinking and good problem-solving skills.
  • Ability to demonstrate a willingness to learn.
  • Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
  • Ability to influence without direct authority.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively in a team environment consisting of internal and external team members.
  • Proficiency with Microsoft Office and scientific relevant software.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Performs other tasks and assignments as needed and specified by management.


Job Specifications

Education and Experience Requirements

Ph.D. in biochemistry, protein chemistry or other related scientific discipline and a minimum of 8 years progressively responsible experience in a pharmaceutical, biotechnology or related environment.

Working Conditions

Office/Laboratory based position.

Confirm Job Qualifier To Apply

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

R&D - Oligonucleotide Conjugation

No Open Roles At This Time

R&D - Molecular Biology/Protein Engineering/Cell Biology

No Open Roles At This Time

R&D - Chemistry

Director – Chemistry

Job Summary

The Director of Bioconjugate Chemistry is responsible for leading the bioconjugate and bioassay groups at NJ Bio. With a specific focus on Antibody Drug Conjugates (ADCs). In this role, you will play a crucial part in advancing cutting-edge therapies that combine the precision of antibodies with the potency of small molecules.

Plan project responsibilities; plan work for each project and execute it towards a timeline while maintaining productivity; plan project execution with starting material quantities and liaise with purchase to follow up on arrivals and help procurement with selection of materials; prepare and present project status and progress updates to clients; provide input on equipment purchases; get regular updates from project group; contribute to scientific discussions; check and maintain up to date lab notebooks for subordinates; supervise Scientists in the Bioconjugation department and Bioassay; maintain performance management metrics for personnel; be a subject matter expert for clients and stay abreast of current literature in scientific areas; write project reports containing procedures and experimental details for clients; maintain equipment, chemical inventory and participate in lab support activities. Perform other duties as required.

Additionally, will represent the company for business development, advise clients on solutions and instituting research plans for bioconjugate development. Be able to implement and allow implementation of new technologies.

The Director ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Manages, coaches, and mentors direct reports.

Job Responsibilities

  • Lead Organization: Oversee the research activities and ensure timeline deliveries when it comes to small molecule synthesis, bioconjugation and bioassays to support clients R&D projects.
  • Scientific Expertise: Stay abreast of industry trends, emerging technologies, and scientific advancements related to ADCs and bioconjugation.
  • Subject Matter Experts: Represent company to clients, support business development and implement new services.
  • Quality Control: Implement robust quality control measures to ensure product integrity and compliance.
  • Team Leadership: Lead and mentor a team of scientists and researchers in the field of bioconjugation and chemistry.
  • Collaboration: Work closely with research, development, and regulatory teams to drive innovation and achieve project goals.
  • Plan work for each project and execute it towards a timeline while maintaining productivity.
  • Plan project execution with starting material quantities and liaise with purchase to follow up on arrivals and help procurement with selection of materials.
  • Provide input on equipment purchases.
  • Supervise and train subordinates; maintain performance management metrics for personnel.
  • Assist with non-assigned projects as needed.
  • Be a subject matter expert for clients and stay abreast of current literature in the scientific area.
  • Obtain regular updates from project group and ensure quality and project timelines are being met.
  • Check and maintain up to date lab notebooks for all subordinates.
  • Prepare and present project status and progress updates to clients.
  • Contribute to scientific discussions.
  • Stay abreast of current literature in scientific areas.
  • Write project reports containing procedures and experimental details for clients.
  • Maintain equipment, chemical inventory, and participate in lab support activities.
  • Complete mandatory assigned trainings


Required Knowledge, Skills, and Abilities

  • Ability to effectively plan and execute projects.
  • Ability to effectively plan the work of others.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to work collaboratively as part of a team.
  • Ability to communicate effectively, orally, in writing and to listen actively with internal and external stakeholders.
  • Ability to apply critical thinking and good problem-solving skills.
  • Ability to demonstrate a willingness to learn.
  • Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
  • Ability to influence without direct authority.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively in a team environment consisting of internal and external team members.
  • Proficiency with Microsoft Office.
  • Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Performs other tasks and assignments as needed and specified by management.
  • Strong Leadership Skills: Ability to inspire and guide a team toward achieving project milestones.
  • Expertise in linker-payload design and bioconjugation, including site-specific and non-specific conjugation.
  • Knowledge of ADC characterization methods, such as HPLC, mass spectrometry, and bioanalytical assays.


Job Specifications

Education and Experience Requirements

Ph.D. in organic chemistry, protein chemistry with a strong background in bioconjugation or in chemistry or other related scientific discipline and a minimum of 8 years progressively responsible experience in a pharmaceutical, biotechnology or related environment.

Working Conditions

Office/Laboratory based position.

 

Confirm Job Qualifier To Apply

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


Scientist- Chemistry

Job Summary

The following is a job summary of the Scientist Chemistry R&D:
Plan and execute chemical syntheses from milligram to hundreds of grams scales; conduct purification and characterization of compounds; ability to troubleshoot reactions, carry out literature searches using chemical database tools and programs; maintain a detailed and accurate lab notebook; communicate with clients and management on progress and project status; stay abreast of current literature in scientific areas; write project reports containing procedures and experimental details for clients at publication quality; maintain time sheets, equipment, chemical and project inventory and provide lab support; Perform other duties as required.

Job Responsibilities

  • Plan and execute chemical syntheses from milligram to hundreds of grams scales.
  • Conduct purification and characterization of compounds.
  • Carry out literature searches using chemical program database (i.e. reaxys, scifinder).
  • Maintain an accurate laboratory notebook according to policy and industry standards.
  • Communicate with clients and management on progress and project status.
  • Stay abreast of current literature in scientific areas.
  • Write project reports containing procedures and experimental details of publication quality for clients.
  • Maintain time sheets, equipment, chemical and project inventory and provide lab support.
  • Stay up to date with the required SOP and EHS on-line training.
  • Perform other duties as required.


Required Knowledge, Skills, and Abilities

  • Ability to plan and execute complex multistep syntheses.
  • Experienced in purification and characterization of compounds.
  • Must have practical and hands-on experience with analytical techniques like Mass Spectrometry and Nuclear Magnetic Resonance.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to work independently and proactively.
  • Ability to work collaboratively as part of a team.
  • Communicates effectively with supervisors and colleagues
  • Ability to communicate scientific data effectively through presentations and reports internally and externally.
  • Experienced in basic computer software and internet applications including: Reaxys, ChemDraw, MS Office suite.
  • Ability to apply critical thinking and good problem-solving skills.
  • Demonstrate a willingness for continued learning.
  • Maintain a culture of safety within the lab and ensure safe work practices are followed.


          Job Specifications

          Education and Experience Requirements

          • Ph.D. in Chemistry with 0-2 years of industry/postdoc experience or M.S. in Chemistry with 5-10 years of industry experience.

          Working Conditions

          • Office/Laboratory based position.

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

          R&D - Project Management

          No Open Roles At This Time

          R&D - Process Development, Bioconjugation

          No Open Roles At This Time

          Manufacturing

          NJ Bio Inc is a growing chemistry and biotech CRO with laboratories located in Princeton, NJ and Bristol, PA. NJ Bio offers competitive salary, great benefits, and significant growth opportunities within the organization. NJ Bio is constantly expanding its team and is looking for dedicated and talented individuals.

           

          Manufacturing Associate II/ III

          Job Summary

          The Manufacturing Associate II/ III is responsible for leading the execution of production activities for multiple active pharmaceutical products (API) including high-potent APIs (HPAPI), mRNAs, and/or drug substances (DS),  and Antibody Drug Conjugates (ADCs) following GMP standards.

          Job Responsibilities

          • Oversees and performs manufacturing operations safely and compliantly in accordance with OSHA and cGMP guidelines. Manufacturing operations include but are not limited to; dispensing and sampling of raw materials, buffer preparation, column packing, UF/DF, chromatography, filtration, product sampling, and filling of bulk product or intermediate.
          • Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.
          • Performs oversight of process operations and monitors equipment and critical process parameters. Escalates any issues or abnormalities to management, senior associates and/or system matter experts. Participates in resulting troubleshooting activities as necessary
          • Completes setup, use and cleaning (as necessary) of cGMP production equipment.
          • Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate.
          • Proactively works with system matter experts, and management to achieve training competency in production operations.
          • Maintains a clean and orderly production area. Positively engages and collaborates with other team members to ensure daily production tasks are completed in a timely manner.
          • Participates in investigations of safety or quality issues as necessary.
          • Participates and supports a culture of continuous improvement. Effectively collaborates with cross functional partners such as Engineering, Quality Assurance, Quality Control, Supply Chain, and Facilities.


          Required Knowledge, Skills, and Abilities

          • Ability to follow detailed instructions and to maintain accurate records and notes.
          • Ability to work effectively in a team environment.
          • Excellent oral and written communication skills
          • Ability to work occasional weekends, holidays or overtime as needed.
          • Familiarity with MS Office applications (Outlook, Word, Excel).
          • Energetic, motivated and dynamic individual.
          • Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.


          Job Specifications

          Education and Experience Requirements

          • High School Diploma / associate degree with exposure to science & math coursework
          • BA/BS degree in a scientific discipline (life sciences / engineering / (synthetic /organic chemistry)– Preferred
          • 2-10 years of cGMP experience

           

          Physical Demands
          Ability to lift up to 20 pounds

          Working Conditions
          Lab/manufacturing environment

          Certificates & Licenses Required
          N/A

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


          Warehouse Associate

          Job Summary

          NJ Bio is looking for a GMP (Good Manufacturing Practice) Warehouse Associate to play a crucial role in maintaining the quality and compliance of materials within a pharmaceutical or biotech warehouse. This position is a day shift, but could vary based on company needs.

          Job Responsibilities

          1. Receiving and Inspection of GMP and non-GMP Materials:

          Receive incoming shipments, label them, and assess stock for damages.
          Inspect critical reagents and materials for quality and compliance.

          2. Inventory Management:

          Maintain accurate stock records and perform inventory control.
          Keep material inventory logs up to date.
          Adequate knowledge of warehouse data systems preferred.

          3. Order Fulfillment:

          Prepare orders for shipment by picking inventory and creating shipping labels.
          Load packages onto delivery trucks.
          Ability to drive a forklift, use a hand truck or pallet jack.

          4. Training and Compliance:

          Complete required training promptly.
          Ensure training status remains in good standing.

          5. Other duties assigned.


          Required Knowledge, Skills, and Abilities

          • Strong organizational skills and attention to detail are essential.
          • Ability to lift, bend, stoop or move products.
          • Ability to be a team player with co-workers and management.
          • Ability to drive a forklift, use a hand truck or pallet jack.
          • Ability to work occasional weekends, holidays or overtime as needed to fulfill the business need


          Job Specifications

          Education and Experience Requirements

          • High School degree
          • At least 1 year of experience in a GMP environment

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


          Manager/Sr. Manager of Chemical Operations

          Job Summary

          The Manager/Sr. Manager will be mainly responsible for managing the day-to-day manufacturing activities of multiple pharmaceutical products ranging from small molecules produced through multi-step chemical synthesis to drug substances such as Antibody Drug Conjugates (ADCs).

          Job Responsibilities

          1. Build, develop, and lead a department that has the capability to manufacture multiple active pharmaceutical products (API) including high-potent APIs (HPAPI), mRNAs, and drug substances (DS) such as Antibody Drug Conjugates (ADCs) following GMP standards.
          2. Coordinate activities with functional groups such as facilities, process engineering (manufacturing sciences and technology (MSAT), Technical Services (qualification/validation & Maintenance), materials management and Quality Assurance that support the manufacturing of GMP materials.
          3. Oversee the department’s finalization of manufacturing campaigns.
          4. Develop short- and long-term technical objectives for the organization that cover manufacturing.
          5. Lead and manage NJ Bio’s manufacturing efforts, collaborating closely with appropriate stakeholders to ensure alignment with the company’s timelines.
          6. Establish project/program milestones and timelines to drive programs through solid leadership, empowerment, and accountability, ensuring that goals are met on time and within budget.
          7. When needed, provide guidance on manufacturing matters to customers/clients/partners/collaborators.
          8. Partner with Quality colleagues and implements appropriate QA/QC process and controls; has a QA/QC first mindset.
          9. Ensure regulatory inspection preparedness planning for customer/client, investor and regulatory agency visits and inspections while understanding and implementing processes, controls, and methods that align with global health authority regulatory expectations.
          10. Perform additional responsibilities as assigned.


          Required Knowledge, Skills, and Abilities

          • >2 years management level experience with ability to develop staff.
          • Excellent interpersonal and communication skills
          • Ability to influence stakeholders and drive decision-making.
          • Proficient in MS Office Software such as Excel, Word, Outlook and PowerPoint.
          • Experience in MasterControl, eQMS, and eBR is a plus.
          • Experience in Unicorn, Opti-Dry, Rockwell Studio is a plus.
          • Knowledge of chemical engineering principles including reaction kinetics, reactor design, chemical thermodynamics, process modeling, heat, and mass transport a plus.
          • Business acumen including experience with Asana, Smartsheet or Microsoft project or equivalent management tool and proven ability to learn and adapt to new systems
          • Understanding and/or experience in chemical process scale-up and manufacturing of pharmaceuticals.
          • Proven record of calm under pressure and a positive attitude.
          • Highly organized.
          • Ability to effectively collaborate.
          • Outstanding communication skills (verbal and written).


          Job Specifications

          Education and Experience Requirements

          Minimum of a Bachelor of Science (BS) in Chemical Engineering, Organic Chemistry, Process Chemistry or Physical Chemistry and a minimum of 5 years of hands-on experience within a GMP regulated pharmaceutical manufacturing environment and multi-step chemical synthesis processes. Prior shopfloor supervisor experience a plus.

          Physical Demands

          Ability to lift 50 pounds.

          Working Conditions

          75% Office environment and 25% manufacturing environment. Ability to work occasional weekends, holidays or work past regular working hours as needed to support manufacturing activities.

          Certifications & Licenses Required

          N/A

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


          Facilities Specialist

          Job Summary

          Oversee work orders, manage manufacturing equipment maintenance and recertification, handle equipment and room cleaning, troubleshoot equipment, conduct GMP inspections, and maintain GMP records. Plus, you’ll be a key player in revising SOPs, boosting equipment reliability, and planning/scheduling facility shutdowns.

          Summary:

          • Compliance: Making sure everything meets strict GMP, safety, maintenance, cleaning standards. Think guardian of our compliant environment!
          • Planning and Organizing: Organizing renovations, working with stakeholders to coordinate and schedule equipment, building shutdowns for maintenance, calibration, recertification works, and capital project executions – all to minimize disruption and keep our space optimized.
          • Leadership: Supervise facilities staff and subcontractors to ensure efficient coordination and execution of work
          • Administrative: Handling records, POs, SOP revisions, GMP logbooks, insurance, and keeping everything documented.
          • Reliability: Proactively maintaining the GMP building and its infrastructure to ensure smooth and reliable operation.
          • Ensures adherence to relevant regulatory requirements and Company Standard Operating Procedures (SOPs) as appropriate.

          Job Responsibilities

          • Creates Scope of Work, Request for Proposals, and Purchase Orders for infrastructure changes, capital projects, lab renovations, mechanical equipment repairs, replacements, and safety equipment maintenance.
          • Negotiates with contractors on pricing proposals in conjunction with facilities engineering.
          • Serves as a liaison for Capital Projects, Environmental Health & Safety, Facilities, and Site Protection, managing renovation and reconfiguration projects for critical utilities, GMP processes and laboratory equipment, offices, and common areas.
          • Initiates project requests, approves designs, and guides affiliated offices, vendors, and contractors, while coordinating project management with capital projects and facilities services.
          • Assigns and monitors cleaning and maintenance responsibilities to contractors and conducts routine GMP and safety inspections (daily facility walk-throughs or as needed), monitoring interior and exterior areas of the building for cleanliness and general upkeep.
          • Handles infrastructure issues affecting buildings (e.g., HVAC, carpentry, electrical, plumbing, DI water, equipment and room certifications, and others).
          • Prepares labs to custom specifications, ensures that equipment is installed upon arrival, and prepares and implements project budgets and timeframes.
          • Supports maintenance and installation work, supervises vendors, and ensures they perform work assignments safely and per contracted terms, including routine maintenance on mechanical, airflow, fluid pumping equipment, electrical, refrigeration, and plumbing repairs.


          Required Knowledge, Skills, and Abilities

          • GMPs and Safety knowledge required, especially in manufacturing environments.
          • Advanced mechanical and plumbing skills related to exhaust fans, boilers, chillers, air compressors, and other utility systems.
          • Collaborate effectively with stakeholders and cross-functional teams.
          • Knowledge of HVAC, EMS, BMS, and other related building systems.
          • Excellent project and time management, as well as multitasking skills.
          • Basic understanding of accounting and finance principles.
          • Strong communication, leadership, problem-solving, and troubleshooting skills.
          • Minimum 3 years of work experience in pharma, biotechnology, or chemistry lab facilities, with certifications such as Boiler Operator or Refrigeration Engineering preferred.
          • Ability to work occasional weekends, holidays or overtime as needed to fulfil the business needs.

          Preferred qualifications

          • Professional leadership experience and contract handling expertise.
          • Experience planning and maintaining facility budgets.
          • Excellent verbal and written communication skills.
          • Strong attention to detail and excellent organizational skills.
          • Ability to exercise independent judgment, prioritize diverse workloads, and creatively solve problems.
          • Ability to manage multiple priorities in a fast-paced, changing environment, take initiative, self-motivate, and work effectively in a team-based environment.


          Job Specifications

          Education and Experience Requirements

          Degree in Mechanical or Chemical Engineering with 3+ years’ experience in facilities management, preferably in pharma, biotechnology, or chemistry lab facilities.

          Physical Demands

          Ability to lift heavy objects (≤50 lb.) and perform other labor-intensive tasks as required.
          Sitting, standing, walking

          Working Conditions

          Office environment/laboratory
          Manufacturing environment

          Certifications & Licenses Required

          N/A

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

          Process R&D

          Process Scientist/ Chemist

          Job Summary

          We are seeking a highly skilled Process Chemist/Scientist to join our team. The successful candidate will work under minimal supervision on various projects, executing chemical syntheses at scales ranging from milligrams to kilograms. This role involves conducting pilot scale synthesis, purifying and characterizing synthesized compounds, and adequately presenting results/progress to internal and external stakeholders. Will need to stay up to date on current literature in scientific areas, maintain laboratory equipment and chemical inventory, provide general lab support and perform additional duties as required. The Process Chemist/Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

          Job Responsibilities

          With minimal supervision:

          1. Conduct hands-on laboratory chemical development to create safe, robust, and scalable processes for kilo-lab operations.
          2. Regularly participate in cross-functional project teams within Research and Development, as well as collaborate with external clients on projects ranging from milligram to multi-gram scales.
          3. Operate kilo-lab equipment to prepare pharmaceutical intermediates, Active Pharmaceutical Ingredients (APIs), and highly potent APIs (HPAPIs).
          4. Apply technical knowledge to safely optimize synthetic organic chemistry processes for scale up into large glassware, support and participate in pilot plant tech transfer projects for APIs and HPAPIs.
          5. Independently characterize molecules using analytical techniques including NMR, MS, HPLC.
          6. Perform pilot scale purifications using Teledyne ISCO and Torrent system purifications.
          7. Performs other tasks and assignments as needed and specified by management.

          Required Knowledge, Skills, and Abilities

          • Must have full working knowledge of and practical experience with analytical instruments and analytical techniques including HPLC, mass spectroscopy, NMR, and purification systems such as Teledyne ISCO purification and Torrent system.
          • Technical knowledge to safely optimize synthetic organic chemistry processes for scale up of APIs, HPAPIs at pilot scale.
          • Good interpersonal skills to be an effective member of a multi-disciplinary team comprised of chemists, bioconjugation, analytical and quality assurance specialists. 
          • Has a working knowledge of cGMP process scale-up and familiarity with compliance requirements within cGMP, SOPs, and regulatory environments.
          • Good problem-solving capability with manager support.
          • Be able to organize work efficiently such that several operations can be carried out simultaneously.
          • Ability to be an individual contributor and a collaborative team member.
          • Ability to apply critical thinking and have good problem-solving skills.
          • Demonstrates a willingness to learn and work proactively.
          • Maintain a culture of safety and ensure safe work practices within the lab.
          • Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission.
          • Communicates effectively with supervisors and colleagues.
          • Able to communicate scientific data effectively through presentations, notebooks, and reports internally and externally.
          • Participate in weekly client updates as needed, prepare weekly reports, contribute to and lead campaign reports and participate in process chemistry technology transfer.
          • Ability to work occasional weekends, holidays or overtime as needed to fulfill the business need.

           

          Job Specifications

          Education and Experience Requirements

          • PhD/MS level in chemistry, preferably organic/synthetic chemistry, or equivalent university degree.
          • 1-3 or more years of industrial experience in pharmaceutical process development for scale up of intermediates and APIs into kilo-lab and pilot plant facilities.
          • 1-3 or more years industrial experience developing processes for scale-up of small molecule pharmaceuticals or HPAPI chemicals is preferred.
          • Experience in a CRO or CMO environment is desirable.
          • Proven track record meeting aggressive targets as related to safe, timely and successful p
          • Ability to prioritize and manage numerous activities simultaneously.
          • Ability to interact in an effective and appropriate manner with diverse population sets.
          • Excellent written, verbal and presentation skills.

          Physical Demands

          • May need to lift heavy objects, up to 40 lbs.

          Working Conditions

          • On-site, laboratory/office environment

          Certificates & Licenses Required

          • N/A

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

          Quality Control

          QC Scientist (I&II)

          The primary role is to provide analytical support for GMP manufacturing and process development. The QC scientist will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), and other pharmaceutical products in a GMP setting.

          Job Responsibilities:  

          1. Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
          2. Work with management and vendors to acquire, install, and qualify new equipment.
          3. Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
          4. Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
          5. Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
          6. Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
          7. Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
          8. Write deviations, change controls, and CAPAs, and/or assist management with these documents.
          9. Document work in laboratory notebooks and logbooks according to organizational GDP policies.
          10. Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
          11. Manage work outsourced to third-party analytical and metrology service providers.
          12. Perform detailed peer review of analytical data to ensure accuracy.
          13. Train and oversee junior scientists.

           

          Required Knowledge, Skills and Abilities  

          • Strong background in analytical sciences.
          • Ability to work independently and in a team setting.
          • Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.

           

          Education and Experience Requirements

          • BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
          • At least 1 year in GMP pharmaceutical QC environment
          • At least 1 year of relevant technical experience (raw materials, LC, GC, etc.)

           

          Physical Demands

          • Typically requires standing and walking for entire shift.
          • Occasionally requires lifting of up to 20 pounds.
          • Frequently requires the use of a step stool.
          • Requires manual dexterity and visual abilities.

           

          Working Conditions

          • Laboratory and office environment

           

          Certificates & Licenses Required

          • N/A

           

           Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


          QC Scientist (Senior and Principal)

          The primary role is to provide analytical support for GMP manufacturing and process development. The QC scientist will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), and other pharmaceutical products in a GMP setting.

          Job Responsibilities:  

          1. Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
          2. Work with management and vendors to acquire, install, and qualify new equipment.
          3. Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
          4. Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
          5. Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
          6. Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
          7. Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
          8. Write deviations, change controls, and CAPAs, and/or assist management with these documents.
          9. Document work in laboratory notebooks and logbooks according to organizational GDP policies.
          10. Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
          11. Manage work outsourced to third-party analytical and metrology service providers.
          12. Perform detailed peer review of analytical data to ensure accuracy.
          13. Train and oversee junior scientists.

           

          Required Knowledge, Skills and Abilities  

          • Strong background in analytical sciences.
          • Ability to work independently and in a team setting.
          • Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.

           

          Education and Experience Requirements

          • BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
          • At least 5 years in GMP pharmaceutical QC environment
          • Relevant experience with ELISA required.
          • Should also have experience in LC or CE-SDS and other techniques.
          • SEC-MALS, cIEF, or DSC highly desirable.

           

          Physical Demands

          • Typically requires standing and walking for entire shift.
          • Occasionally requires lifting of up to 20 pounds.
          • Frequently requires the use of a step stool.
          • Requires manual dexterity and visual abilities.

           

          Working Conditions

          • Laboratory and office environment

           

          Certificates & Licenses Required

          • N/A

           

           Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


          QC Team Lead

          The QC Team Lead is a hands-on laboratory position with additional supervisory and management responsibilities. The QC Team Lead will manage a group of QC scientists. The QC Team Lead will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), nucleic acids, and other pharmaceutical products in a GMP setting.

          Job Responsibilities

          1. Manage and lead a group of junior scientists.
          2. Schedule team work assignments based on project deadlines.
          3. Perform detailed peer review of analytical data to ensure accuracy.
          4. Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
          5. Work with management and vendors to acquire, install, and qualify new equipment.
          6. Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
          7. Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
          8. Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
          9. Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
          10. Conduct OOS, risk assessment, and root cause investigations and/or assist senior management with these investigations.
          11. Write deviations, change controls, and CAPAs, and/or assist senior management with these documents.
          12. Document work in laboratory notebooks and logbooks according to organizational GDP policies.
          13. Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
          14. Manage work outsourced to third-party analytical and metrology service providers.

           

          Required Knowledge, Skills and Abilities  

          • Experience in leading people and projects
          • Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
          • Knowledge and experience in cGMP, ICH guidelines, USP, and Ph.Eur.

           

          Job Specifications

          Education and Experience Requirements

          • BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
          • Experience in a GMP manufacturing or CRO setting.
          • BS with at least 5 years of relevant experience, MS or higher degree with at least 4 years of relevant experience, or equivalent combination of work experience, education, and training

           

          Physical Demands

          • Typically requires standing and walking for entire shift.
          • Occasionally requires lifting of up to 20 pounds
          • Frequently requires the use of a step stool
          • Requires manual dexterity and visual abilities

           

          Working Conditions

          Laboratory and office environment

           

          Certificates & Licenses Required

          N/A

           

           Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


          QC Data Reviewer

          The primary role of the QC Data Reviewer is to perform peer data review QC and AR&D analytical data to support GMP manufacturing and process development. The QC Data Reviewer will review raw data, laboratory notebooks, logbooks, forms, protocols, reports, etc.

          Job Responsibilities

          1. Perform detailed peer review of analytical data to ensure correctness, accuracy, data integrity, and compliance.
          2. Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
          3. Assist with sample management, supply inventory, housekeeping, and other lab maintenance and support activities as assigned.
          4. Prepare standard operating procedures (SOPs), protocols, reports, specifications, labels, certificates, etc. as needed.
          5. Assist senior management with audits, inspections, OOS, risk assessment, and root cause investigations.
          6. Write deviations, change controls, and CAPAs, and/or assist senior management with these documents.
          7. Review analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
          8. Other duties as assigned.

           

          Required Knowledge, Skills and Abilities  

          • Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
          • Extensive knowledge and experience in cGMP, data integrity, ICH guidelines, USP, and Ph.Eur.
          • Excellent written and oral communication skills.
          • Analytical mindset, critical thinking skills, and attention to detail
          • Proficient in various data acquisistion and processing platforms, including Empower and SoftMax.

           

          Job Specifications

          Education and Experience Requirements

          • BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
          • Experience in a GMP manufacturing or CRO setting.
          • BS with at least 3 years of relevant experience, MS or higher degree with at least 2 years of relevant experience, or equivalent combination of work experience, education, and training

           

          Physical Demands

          • Typically requires standing and walking for entire shift.
          • Occasionally requires lifting of up to 20 pounds
          • Frequently requires the use of a step stool
          • Requires manual dexterity and visual abilities

           

          Working Conditions

          Laboratory and office environment

           

          Certificates & Licenses Required

          N/A

           

           Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

          Analytical Chemistry

          NJ Bio Inc is a growing chemistry and biotech CRO with laboratories located in Princeton, NJ and Bristol, PA. NJ Bio offers competitive salary, great benefits, and significant growth opportunities within the organization. NJ Bio is constantly expanding its team and is looking for dedicated and talented individuals. We currently have the following job openings in Analytical Chemistry department:

           

           

          Senior Scientist, Analytical Chemistry

          Independently work on all aspects of analytical methods, including method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following:  LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.

          Job Responsibilities:  

          • Develop and execute independently and/or collaboratively all aspects of analytical methods to support Bio-conjugation team, process development, product development, QC, in-process monitoring, stability studies, and drug substance.
          • Works on analytical method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
          • Author analytical test methods, protocols, reports, and other documents
          • Act as an intellectual resource in area of expertise by supporting assay troubleshooting, investigations, and improving analytical methods
          • Play a key role in improving processes and procedures
          • Lead and actively participate in project teams
          • Review and interpret complex data and perform statistical analyses using appropriate software
          • Communicate scientific data and concepts effectively through presentations, protocols, test methods, and reports internally and externally.
          • Maintain a culture of safety and ensure safe work practices within the AMD lab
          • Adheres to EHS and quality standards set by regulations and company policies, procedures, and mission.
          • Communicates effectively with supervisors, colleagues, clients, and vendors.
          • Participates in scientific discussions; stays abreast of current literatures in scientific areas;
          • Performs duties as required.

           

          Required Knowledge, Skills and Abilities:  

          • Must have practical and hands-on experience with analytical instruments and method development using instruments such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods
          • Must be able to handle complex data interpretation software and perform statistical analyses
          • Be able to work on multiple projects simultaneously
          • Ability to be an individual contributor and collaborative team member
          • Ability to apply critical thinking and good problem-solving skills
          • Demonstrates a willingness to learn and work pro-actively.
          • Able to communicate scientific data effectively through presentations, protocols, test methods, and reports internally and externally.
          • Maintain a culture of safety and ensure safe work practices within the lab
          • Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission.
          • Communicates effectively with supervisors and colleagues
          • Must have knowledge of cGMPs specially wrt to analytical method transfer etc.

           

          Job Specifications

          Education and Experience Requirements

          • Ph.D. or Masters in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas
          • 2 – 4 years of experience in analytical method development and problem solving in the pharmaceutical industry required for this position
          • GMP experience is a plus.

           

          Physical Demands
          N/A

          Working Conditions
          Lab

          Certificates & Licenses Required
          N/A

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


          Scientist, Analytical Chemistry

          Working experience in all aspects of analytical methods, including method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.

          Job Responsibilities:  

          1. Develop analytical methods to support Bio-conjugation team, process development, product development, QC, in-process monitoring, stability studies, and drug substance independently or minimal supervision.
          2. Works on analytical method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
          3. Author analytical test methods, protocols, reports, and other documents
          4. Act as an intellectual resource in area of expertise by supporting assay troubleshooting, investigations, and improving analytical methods
          5. Play a key role in improving processes and procedures
          6. Lead and actively participate in project teams
          7. Review and interpret complex data and perform statistical analyses using appropriate software
          8. Communicate scientific data and concepts effectively through presentations, protocols, test methods, and reports internally and externally.
          9. Maintain a culture of safety and ensure safe work practices within the AMD lab
          10. Adheres to EHS and quality standards set by regulations and company policies, procedures, and mission.
          11. Communicates effectively with supervisors, colleagues, clients, and vendors.
          12. Participates in scientific discussions; stays abreast of current literatures in scientific areas.
          13. Performs duties as required.

           

          Required Knowledge, Skills and Abilities:  

          • Must have practical and hands-on experience with analytical instruments and method development using instruments such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods
          • Must be able to handle complex data interpretation software and perform statistical analyses
          • Be able to work on multiple projects simultaneously
          • Ability to be an individual contributor and collaborative team member
          • Ability to apply critical thinking and good problem-solving skills
          • Demonstrates a willingness to learn and work proactively.
          • Able to communicate scientific data effectively through presentations, protocols, test methods, and reports internally and externally.
          • Maintain a culture of safety and ensure safe work practices within the lab
          • Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission.
          • Communicates effectively with supervisors and colleagues
          • Must have knowledge of cGMPs.
          • Working experience with small and large molecule experience is plus.

           

          Job Specifications

          Education and Experience Requirements

          • Ph.D. or Masters in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas
          • More than two years of experience in analytical method development and problem solving in the pharmaceutical industry required for this position
          • GMP experience is required.

           

          Physical Demands
          N/A

          Working Conditions
          Lab

          Certificates & Licenses Required
          N/A

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.


          Senior Scientist – Bioanalytical Characterization

          NJ Bio, Inc. is a rapidly growing chemistry and biotech CRO with laboratories in Princeton, NJ and Bristol, PA. NJ Bio offers competitive salaries, great benefits, and significant growth opportunities. NJ Bio is constantly looking to expand its team and looking for dedicated and talented individuals – NJ Bio is looking to hire a Senior Scientist in Bioanalytical for ADCs, large molecules.

          Job Responsibilities:  

          • Develop and perform cell-based assays in support of the client projects for mAb, ADCs, and mRNA vaccines.
          • Develop and optimize immunological and ligand binding assays, such as SPR, flow cytometry, immunoblot, and ELISA.
          • Analyze data, trouble-shoot experiments, and meet timelines.
          • Record experiments in notebook
          • Prepare results in PowerPoint or equivalent and present them in client meetings.
          • Summarize and communicate results to supervisor in a logical and effective manner.
          • Present data at meetings within the group or with external client meetings.
          • Write methods, protocols, and reports, and validate/qualify the methods.
          • Develop plate-based assays for process related residual impurities such as DNA, RNA, protein, etc.

           

          Required Knowledge, Skills and Abilities

          Required Experience and Skills:

          • Subject matter expert with extensive experience in bioassays and ELISA.
          • Deep knowledge and expertise in development, qualification/validation, and troubleshooting of assays for vaccines, mAb’s, ADCs, and proteins.
          • Familiarity with Good Manufacturing Practices (GMP) is strongly desired.
          • Ability to independently analyze and interpret experimental data and to present and discuss results within a multi-disciplinary team environment.
          • Adherence to safety procedures 
          • A team player with excellent oral and written communication skills 
          • Ability to work independently and as a scientific mentor for development and qualification/validation of assays.

           

          Preferred Experience and Skills:

          • Experience with immunological assays such as ELISA, AlphaLISA, multiplexed ligand binding assays (LBA) on Meso Scale Discovery and/or Luminex platforms.
          • Experience with microplate imaging systems and multiplex plate readers preferred. 
          • Familiarity with liquid handlers and other automation platforms for sample preparation and assay process is preferred.
          • Experience in new assay technology evaluation.

           

          Job Specifications

          Education and Experience Requirements

          • PhD in Biological Sciences such as Immunology, Virology, Cell Biology, Biochemistry, or related areas with 4+ years of relevant experience.
          • MS degree and 8+ years of relevant experience will also be considered.
          • BS degree and 12+ years of relevant experience will also be considered.

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

          Quality Assurance

          Quality Assurance Manager

          Job Summary
          The Manufacturing Quality Assurance (MQA) Manager provides leadership and support to all  Quality Operations (QO) regulatory compliance activities to ensure all federal, state, global regulatory agency and NJ Bio requirements are met. . This is a highly independent position operating with minimal supervision, interacting with high levels of management both at NJ Bio and external clients.  The MQA Manager will be expected to operate as a spokesperson for the Executive Director of QO and Vice-President of QO in their absence with strong negotiation and communication skills and building relationships. The MQA Manager takes initiatives, independently negotiates issues, develop and communicate NJBio quality requirements with internal and external stakeholders and is proactive. The incumbent must have a strong broad Good Manufacturing Practice (GMP) and technical know-how to handle emerging issues applicable to clinical and commercial operations.  In addition, the incumbent will lead a team of quality professionals and ensure the implementation of NJ Bio’s Quality Management System as required.

          Key Responsibilities

          Responsibilities include but not necessarily be limited to, the following:

          • Training and Development: Ensure direct reports are adequately trained and continue to receive training on current GMPs (cGMPs), safety, OSHA, technical skills, policies, and procedures.  Ensure the training documentation is accurate and only trained colleagues are allowed to perform functions. Assures overall quality/integrity of NJ Bio products manufactured and distributed based on phase appropriate cGMPs and industry standards.  Trains or assists in the training of QO and/or all personnel at NJ Bio as needed.
          • Performance: Use situational leadership skills and encourage full participation and teamwork.  Commit to developing people, conducting performance appraisals, providing continuous feedback, creating an inclusive environment, and promoting mutual accountability.  Provides leadership for the QO Manufacturing Assurance unit and QO team, as needed.
          • Integrity: Make decisions and take actions that are consistent with the highest standards of business and personal ethics.
          • Support Phase I/II Clinical Manufacturing Campaigns and Clinical Shipments process end to end.
          • Ensure that all products manufactured at NJ Bio meet applicable global and local market cGMP requirements.
          • Write, review, revise and approve SOPs, batch records, material specs and test records and meet with clients on batch record related concerns.
          • Direct and/or perform data and document review and approval of  Clinical Batch Records, QC Test Records, Stability and Validation documents for APIs/intermediates/starting materials for clinical manufacture and all other applicable cGMP records as warranted.
          • Assist with the disposition of Clinical Product, review CoAs, and CoCs
          • Trend and report QA related information (Deviations, CAPAs, EM excursions, Non-conformances, Change Controls etc.)
          • Work closely with the Manufacturing team or applicable departments to investigate and resolve processing quality and compliance issues in a timely manner.
          • Manage the system that supports raw material release, final product release, new product transfers, specifications, stability and client complaints.
          • Data Integrity: Assures that all quality documentation (electronic or paper) utilized in the manufacture, testing, holding and distribution of NJ Bio products meet global cGMP and regulatory requirements.
          • Audit/Inspection Readiness:
            • Assists in the establishment of systems to assure the audit readiness of all manufacturing, testing, holding and distribution documentation for NJ Bio products.
            • Implements strong communication networks of information flow to and from the plant sites, senior management, staff groups and regulatory agencies.
            • Serve as an audit and regulatory inspection escort and/or scribe, as needed. Provide daily audit/inspection notes upon review of team leader.
            • Manage the inspection reports and coordinate the corrective actions; provide audit/inspection CAPA verification status updates to Management Review Board (MRB)
          • Internal/External Audits:
            • Ensures that the annual internal audit schedule is issued and approved as required by procedures.
            • Leads and/or participates in the performance of both internal and external audits.
            • Ensures that audit reports are issued in a timely manner as required by procedures.
            • Ensures CAPA effectiveness follow-ups are performed and properly documented.
          • Actively engage to support site leadership initiatives
          • Demonstrate a passion for Colleague Engagement and is an active change agent.
          • Engaged in monitoring changes in the external regulatory community and actively communicating relevant changes in regulatory and industry expectations to support NJBIO operations.
          • Ensure competency as Super user and/or administrator of Master Control
          • Ensures MQA presence at site to support variable shift manufacturing schedule.
          • Perform other job-related functions as needed or requested.


          Required Knowledge, Skills, and Abilities

          • Demonstrated ability to  handle multiple client projects, to prioritize work, to act and work independently and to report items needing attention to Team Leader
          • Advance user-level of Microsoft 365 applications (MSWord, Excel, SharePoint, Teams, Power Point, etc.
          • Strong written and interpersonal communication skills
          • Ability to write and present reports/investigations and host meetings to support Quality Systems
          • Ability to train employees in a small/large group setting.
          • The ability to work as part of a team.
          • Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.
          • Ability to manage and lead a team.


          Job Specifications

          Education and Experience Requirements

          • Bachelor Science degree in Chemistry/Biology or related discipline
          • 6+ years QA experience in Biotech/Pharma industry or combination of QA/MFG or QC experience
          • Strong understanding of QC test methods, stability procedures and environmental monitoring programs
          • Strong compliance knowledge of GMP Quality Systems, policies, and regulations
          • Strong working knowledge of CFRs, ICH guidelines, and Data Integrity principles
          • Strong understanding of Biopharmaceutical Manufacturing Operations
          • Internal/external auditing experience
          • Review of validation documentation and requirements

          Physical Demands
          N/A

          Working Conditions
          Office and lab environment.

          Certificates & Licenses Required
          N/A

           

          Confirm Job Qualifier To Apply

           

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

          Business Development

          No Open Roles At This Time

          Human Resources

          No Open Roles At This Time

          Platform Innovation

          No Open Roles At This Time

          Finance

          No Open Roles At This Time

          Other

          IT System Administrator

          Job Summary
          The System Administrator’s role is to ensure the stable operation of NJBio’s computer network and infrastructure. This includes planning, developing, installing, configuring, maintaining, supporting, and optimizing all network hardware, servers, desktops/laptops, software, and communication links. The system Administrator will provide technical support within our laboratory environment with a focus on laboratory-specific software and hardware. Frequently collaborate with Quality Assurance and Validation to ensure data integrity and compliance of laboratory systems.

          Job Responsibilities

          • Manage and maintain a Hybrid Azure Active Directory environment, ensuring seamless integration and consistent performance across on-premises and cloud services.
          • Configure and support Ubiquity networking infrastructure to ensure reliable and secure connectivity.
          • Oversee the installation, configuration, and maintenance of various licensed software, ensuring compliance with licensing agreements.
          • Perform regular system backups, disaster recovery operations, and security assessments to protect data integrity and confidentiality.
          • Assist laboratory staff with the installation, configuration, and ongoing usability of desktop computers, peripheral equipment, and software within established standards and guidelines.
          • Ensure desktop computers interconnect seamlessly with diverse systems, including file servers, computer conferencing systems, and laboratory equipment.
          • Provide all levels of support for all laboratory IT-related issues, including software, hardware, and networking problems.
          • Work with vendor support contacts to resolve technical problems with desktop computing equipment and software.
          • Maintain inventory of all equipment, software, and software licenses.
          • Respond to emergency after-hours issues as needed.


          Required Knowledge, Skills, and Abilities

          • Familiarity with laboratory information systems (LIS), electronic lab notebooks (ELN), or scientific data management systems (SDMS) is highly desirable.
          • Familiarity with the following laboratory Software systems: Empower 3, Masslynx, Softmax, Agilent
          • Familiarity with the following laboratory instrumentation: HPLC, Mass Spectrometry, LCMS, NMR, FTIR
          • Understanding of the following Pharmaceutical Regulations/Guidelines: 21CFR Part 11, GxP, GAMP 5
          • Familiarity with the following Quality systems: Electronic Batch Records, QMS, CSV
          • Ability to communicate technical information, both verbal and written, to a non-technical audience.
          • In-depth knowledge of Active Directory, Group Policy, DNS, DHCP, and file/print services.
          • Proficiency in managing Microsoft 365 services, including Exchange Online, SharePoint Online, and Teams.
          • Strong understanding of computer systems, mobile devices, and other tech products.
          • Experience in tracking IT support tickets.
          • Flexibility to handle multiple tasks and meet deadlines.
          • Excellent troubleshooting and problem-solving skills.
          • Ability to work independently and as part of a team.
          • Strong organizational skills and attention to detail.


          Job Specifications

          Education and Experience Requirements

          • Minimum of 5 years’ experience as a tier 3 Support or System Administrator Required
          • Minimum 1 year experience in a GxP environment preferred
          • A bachelor’s degree or an equivalent combination of education and experience.
          • Excellent collaboration and communication skills.

          Physical Demands
          Ability to lift up to 50lbs

          Working Conditions
          Office environment/laboratory

          Certificates & Licenses Required
          Comptia, A+, Network +, Security +

           

          Confirm Job Qualifier To Apply

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

          NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.