Careers

No Open Roles At This Time

No Open Roles At This Time

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.

No Open Roles At This Time

No Open Roles At This Time

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.

MSAT/Process Engineer – Various Levels

Job Summary
The MSAT/Process Engineer will support the GMP manufacturing of small molecules/ nucleic acids/ antibody conjugate with or without limited supervision and guidance. This role will collaborate effectively with personnel in Manufacturing, Engineering, Research and Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.

Key Responsibilities

• Responsible to ensure chemical/bioprocessing equipment are ready for use when required
• Identifies technical issues on chemical/bioprocessing equipment and recommends activities to resolve the issue. Identifies and implements procedures and activities to prevent the same issue from occurring.
• Lead efforts in troubleshooting out-of-trend manufacturing processes, providing the intellectual, scientific and engineering leadership to identify and implement corrective actions.
• Provides guidance and is accountable for determining the root causes of equipment and process related deviations in a timely and conclusive manner.
• Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities.
• Provides comprehensive training and guidance to operations staff.
• Partner with Process Development to ensure successful process transfer.
• Assist in equipment selection and design, qualification, and start up activities. Work with subject matter experts to ensure robust procedures are utilized for operation of equipment.
• Work with the Validation team to develop and execute validation/qualification strategies.
• Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains.

Required Knowledge, Skills, and Abilities

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
• Represents the organization in a positive and professional manner.
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others.
• Excellent organizational and time management skills with ability to set own priorities in a timely manner.
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods.
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
• Demonstrated ability to work in a cross functional team.
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements.
• Always observe safety precautions and regulations in all areas where duties are performed.
• Responsible for reporting all safety hazards and potential unsafe working conditions.

Job Specifications

Education and Experience Requirements

• BS in Chemical/Biochemical Engineering or other relevant discipline required.
• MS in related discipline preferred.
• Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, or process development required.
• 3 – 10 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience required.

Physical Demands
N/A

Working Conditions
Office environment with some 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.

Head of Manufacturing – AD/Director Small molecules

Job Summary

The Head of Manufacturing will be mainly responsible for managing the manufacturing of multiple pharmaceutical products for small molecules and biological therapy entities and drug substances such as Antibody Drug Conjugates (ADCs).

Job Responsibilities

• 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.
• Coordinate activities with functional groups such as facilities, process engineering (manufacturing sciences and technology (MSAT), Technical Services (qualification/validation & Maintenance), and materials management that support the manufacturing of GMP materials.
• Oversee the department’s finalization of manufacturing campaigns.
• Develop short- and long-term technical objectives for the organization that cover manufacturing.
• Lead and manage NJ Bio’s manufacturing efforts, collaborating closely with appropriate stakeholders to ensure alignment with the company’s timelines.
• 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.
• Work with senior leadership to evaluate customers/clients and recommend decision on manufacturing capability.
• Provide guidance on manufacturing matters to customers/clients/partners/collaborators.
• Represent the company, addressing aspects of the company’s manufacturing capabilities.
• Partner with Quality colleagues and implements appropriate QA/QC process and controls; has a QA/QC first mindset.
• Partner with Process R&D colleagues to ensure technical transfer of manufacturing process from lab/pilot scale to GMP.
• 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.
• Perform additional responsibilities as assigned.

Required Knowledge, Skills, and Abilities

• >15 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 and/or biologics.
• 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 15 years of experience within pharmaceutical, biotech or CDMO industries. GMP experience a plus.

Physical Demands
N/A

Working Conditions
Office environment with some 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.

Senior Facilities Engineer

Job Summary
An experienced and driven Facilities Engineer with 5+ years of experience in Facilities Engineering within the pharmaceutical industry.

The incumbent works cross-functionally with internal departments and external resources.

The Senior Facilities Engineer supports adherence to relevant regulatory requirements and company standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Support and execute validation protocols for facilities, utilities, and equipment in compliance with GMP regulations.
•  Support validation and maintenance activities, including but not limited to HVAC, water for injection (WFI), pure steam, feed water, process waste neutralization, clean dry air, and so on.
•  Conduct risk assessments and gap analyses to identify areas for improvement in facilities and utilities validation.
• Assess and manage change controls and deviations related to facilities and utilities validation.
• Implement corrective and preventive actions (CAPAs) as necessary.
•  Support system improvements, development of detailed specifications, engineering documents and standard operating procedures (SOPs).
•  Participate in the development of validation master plans, protocols, analysis of test results, and preparing technical reports.
•  Additional responsibilities as required.

Required Knowledge, Skills, and Abilities

• In-depth knowledge of GMP regulations and validation principles.
• Experienced in HVAC systems.
• Experience with utilities in the following: Water for Injection (WFI), Pure Steam, Feed Water, Process Waste Neutralization, Clean Dry Air, etc.
• Experience with risk-based validation approaches.
• Strong understanding of change control and deviation management.
• Excellent documentation and organizational skills.
• Excellent problem-solving skills and attention to detail.
• Effective communication skills, with the ability to collaborate across diverse teams.
• Some of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
• Proficiency with Microsoft office, Vizio, CAD a plus

Job Specifications

Education and Experience Requirements

• Bachelor’s degree in related engineering discipline, advanced degree preferred.
• Preferred Management experience.
• Preferred EH & S (Environmental Health and Safety).
•  5+ years of facilities and utilities validation experience in the pharmaceutical industry.

Physical Demands
Able to lift over 50 lbs

Working Conditions
Walking and sitting, evaluating facility, making general rounds (dual role – facilities and technical system check)

Office environment with some 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.

Manufacturing Associate II

Job Summary

The Manufacturing Associate II is responsible for the execution of production activities for early phase small molecule and/or biological programs within a GMP environment. 

Job Responsibilities

• 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 senior associates, 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 or BA/BS degree in a scientific discipline (synthetic /organic chemistry)
• About 2 years of cGMP experience.
• Strong desired background in science, technology, and manufacturing. 

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.

Manufacturing Associate III

Job Summary

The Manufacturing Associate 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
• 5-10 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.

No Open Roles At This Time

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.

Primary 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.

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 Senior Scientist

The primary role of the QC senior scientist is to provide analytical support for GMP manufacturing and process development. The QC senior 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 in chemistry, biology, biochemistry, or related discipline. 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.
• 5 years of experience in a GMP manufacturing or CRO setting.

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

The primary role of the QC scientist 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 degree in chemistry, biology, biochemistry, or related discipline.
• 0-4 years’ experience in a GMP manufacturing or CRO setting.

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.

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, 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.

Primary 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.

Education Minimum Requirement:  

• 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.

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.

 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, 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.

Quality Assurance Specialist I-IV

NJ Bio is hiring a Quality Assurance Specialist I-IV. This individual will support clinical manufacturing operations. This individual will provide oversight of manufacturing activities from a quality perspective with limited supervision.

Required Qualifications:

• Oversight (with limited supervision) of clinical manufacturing activities (phase 1, phase 2 of APIs, ADCs) , including area clearance, issuance, and review of batch records, and making decisions on initiation of deviations and investigations.
• Oversight (with limited supervision), review, and approval of Materials Management and supply activities.
• Revision and/or review and approval of SOPs, Protocols, Reports, and Batch Records for continuous improvement.
• Support of Environmental Monitoring Program including Controlled Environments and Clean Utilities.
• Initiation of Discrepancies, including Deviations and Investigations
• Support of implementation of CAPA as determined.
• Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods.
• Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
• Provide basic support during compliance inspections conducted by external sources (i.e. health authorities)
• Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators.
• Perform other job-related functions as needed.

Required Skills:

• Able to handle multiple client projects for Quality requirements.
• Strong knowledge of Microsoft Word, Excel, and Power Point.
• 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 group setting.
• The ability to work independently and as part of a team.

Required Education/Experience:

• Bachelor Science degree in Chemistry/Biology or related discipline
• 0-5 years QA experience in Biotech/Pharma industry or combination of QA/MFG or QC experience or in GMP environment. Level at hire will be based on years of experience.
• Working knowledge of GMPs and their application to biotech/pharma/phase 1 and 2 clinical manufacturing
• Strong compliance knowledge of GMP Quality Systems, policies, and regulations
• Must be able to interpret applicable GMP standards and objectively decide on items with management support.
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.

Job Type: Full-time and on-site

 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 Manager

The Quality Assurance Manager supports Quality Assurance functions focused on manufacturing operations. The position will review/audit complex documents including batch records and QC data; ensure compliance to defined Quality System procedures; conduct moderate/high level information analysis; assure compliance to specifications and standards by performing production and quality control audits. In addition, they will prepare audit reports with proposed corrective actions and complete follow up on corrective actions; assist with training other employees in compliance and quality systems; write and revise standard operation procedures and related manufacturing documents and assist with investigations related to manufactured products.

Responsibilities:

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

• Support Phase I/II Clinical Manufacturing Campaigns and Clinical Shipments
• Write, review, revise and approve SOPs, batch records, material specs and test records and meet with clients on batch record related concerns
• Perform data and document review for Batch Records, QC Test Records, Stability and Validation documents for APIs for clinical manufacture
• Create and maintain batch record process
• Review and approve Quality System documentation
• Assist with disposition of Clinical Product, review CoAs, and CoCs
• Conduct audits (Internal, Vendors, Suppliers, Sub-Contractors Testing Facilities)
• Trend and report QA related information (Deviations, CAPAs, EM excursions, Non-conformances, Change Controls etc.)
• Initiate, investigate, close out deviations
• Oversee Environmental Monitoring Alert/Action Program
• Support the stability program through review of protocols, reports, and data
• Confirm Clinical Site Essential Documents are in place for initial drug supply shipments
• Perform and review area clearance for clinical manufacturing
• Write, review and approve protocols including Manufacturing, Test Method, Equipment (IQ, OQ, and Process Validation, Cleaning Validation) etc.
• Review method and process reports for compliance
• Raw material, GMP components, finished product/API review and disposition
• Assignment of equipment numbers and review of Calibration certificates and OOTs in manufacturing area
• May assist departments with investigations related to manufactured products
• Manage cross departmental process improvements in cGMP area including recommending for continuous improvement projects
• Personnel training on cGMPs and compliance
• Ensure QMS, SOPs, specifications are compliant
• Perform gap analysis of all documents related to standardization of format, quality, training, manufacturing, and equipment procedures and recommend continuous improvements including standardizing training and procedures for documentation
• Super user and administrator of MasterControl
• Train document control specialist/QA specialist
• Support review of client INDs for submission
• Willingness to travel
• Perform other job-related functions as needed

Required Skills:

• Able to handle multiple client projects for Quality requirements
• Strong knowledge of Microsoft Word, Excel, and Power Point
• 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 group setting
• The ability to work independently and as part of a team
• Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required

Required Education/Experience:

• 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 and ICH guidelines
• Strong understanding of Biopharmaceutical Manufacturing Operations
• Internal/external auditing experience
• Review of validation documentation and requirements

Job Type: Full-time and on-site

 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.

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

Controller

Job Summary

The Controller will play a pivotal role in overseeing the financial operations of the dynamic and rapidly growing organization. This position reports to the (CFO) Chief Financial officer and you will be responsible for ensuring the accuracy, integrity and transparency of the financial reporting processes, as well as providing strategic guidance to support the companies mission and objectives.

Job Responsibilities

• Develop annual budgets and forecasts in collaboration with department heads and senior management.
• Monitor budget performance and provide variance analysis reports to identify areas for improvement and cost-saving opportunities.
• Update forecasts regularly based on changing business conditions and performance trends.
• Manage cash flow, including forecasting cash needs and optimizing cash utilization.
• Oversee accounts receivable and accounts payable functions to ensure timely invoicing and payment processing.
• Implement cash management strategies to maximize liquidity and minimize financial risk.
• Lead and mentor a team of finance professionals, providing guidance and support to foster their professional growth.
• Conduct performance evaluations and provide feedback to ensure high performance and productivity.
• Forecasting, Budgeting, Cash flow maintenance is a focus within this position.
• Ability to be a leader within the finance department.

Required Knowledge, Skills, and Abilities

• Ability to drive results through a strong attention to detail, proactive approach to problem solving, and great partnership and negotiation skills.
• Strong consultation, persuasion and influencing skills to support communication of new business needs.
• Ability to synthesize financial information into a concise story and communicate it effectively, leveraging strong interpersonal, written and verbal communication skills.
• Cross-functional collaboration
• Financial planning and forecasting

Job Specifications

Education and Experience Requirements

Qualifications:

• A minimum of a bachelor’s degree, in Finance or Accounting or MBA.
• Active CPA is a must and the ability to take regular classes to keep up to date with constantly changing accounting rules.
• Ability to supervisor one employee who is a certified CPA.
• Experience in SOX (Sarbanes Oxley) and internal control skills.
• Experience with ASC606 and ASC842 is preferred.
• Minimum of 8 years finance or accounting experience, with strong knowledge of financial processes & ledger systems.
• Prior People management/Talent development experience.
• Experience within the Pharmaceutical sector is preferred.
• Advanced/Expert level PowerPoint (Charting/Waterfalls) Excel and MS Office skills are required.
• The ability to autonomously solve problems and influence executives is strongly preferred.

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.

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 person will also analyze and resolve end user hardware and software computer problems in a timely and accurate fashion, and provide end user training where required.

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, email servers, computer conferencing systems, and laboratory equipment.
• Provide first and second-level 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.
• 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 2 years of experience, 5 years preferred, in help desk or technical support, preferably in a laboratory or scientific research environment.
• 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.