Careers
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:
Analytical R&D and Quality Control
*We kindly request that agencies and recruiters do not contact us regarding this position.
Director, Analytical Research & Development
Job Summary
The Director, Analytical Research & Development, will lead the analytical development activities of client projects including small molecule linker payload, APIs, intermediates, monoclonal antibodies, proteins, antibody drug conjugates and other therapeutic modalities. Responsible for analytical method development/qualification, product characterization, leading the teams, preparing the presentation for the client meetings and supporting the management team in other activities as needed. He/she will contribute to setting analytical strategy, working with clients on analytical work strategies, and in partnership with internal and external Quality colleagues to play key role in the development. The incumbent works cross-functionally with internal departments and external resources on Analytical Research & Development related issues. He/ she manages direct reports. The Director, Analytical Research & Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Working closely with clients, monitoring client projects and addressing technical challenges in a timely manner.
- Provide strategic, managerial, and technical leadership to the Analytical Development team.
- Design and execute phase-appropriate analytical strategies, including method development, qualification, and validation for ADCs and small molecule drug substances and drug products.
- Lead a team of 4 to 6 senior/principal/group leaders.
- Complex data interpretation, perform statistical analyses, summarize the results, and effectively present data internally and externally.
- Develop and set specifications for raw materials, intermediates, drug substances, excipients, and drug products.
- Establish and manage stability programs for non-GMP and cGMP drug substance and drug product batches.
- Lead the analytical development projects, prepare the teams for client meetings, and review the presentations with the scientists before presenting with clients.
- Lead method development and qualification/validation of physical chemical analytical methods for oligonucleotide, mRNA, mAb, ADCs and linker payload characterization, release, and stability testing
- Manage analytical method transfers from clients for clinical phase GMP testing, and support process technology transfer to cGMP.
- Manage relationships with existing and new clients, including managing timelines and cost for the analytical development in support of manufacturing activities.
- In collaboration with Quality Control, set product release and stability/shelf-life specifications
- Support business development and proposal management teams in writing new proposals and pricing for potential new clients.
- Working on new technology opportunities to support client projects.
- Author, review and approve relevant analytical test methods, qualification/validation/method transfer protocols and reports.
- Author, review and approve relevant Analytical and quality control and other quality related SOPs.
- Manages, coaches, and mentors direct reports
- Perform other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Knowledge of control strategy for large molecules, drug substance and drug products, phase appropriate method qualifications.
- In-depth mass spectrometry expertise and experience in characterization of ADC’s, mAb’s, proteins and their associated variants and impurities is required.
- In-depth understanding of product characterization of large molecules including ADCs’, monoclonal antibodies and proteins
- In-depth technical understanding of early and late-stage development of ADC products, including CMC Regulatory, Process/Analytical Development, and GMP Manufacturing and QC release and stability testing.
- Leadership and management experience of internal departments.
- Proven leadership experience and understanding influence skills with the desire and ability to work in a fast-paced, collaborative environment. Strong collaboration and team building, communication, and organizational skills required.
- Ability to influence without direct authority.
- Demonstrated leadership ability and experience managing, coaching and mentoring direct reports
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills include the ability to support and prioritize multiple projects.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil business needs.
Job Specifications
Education and Experience Requirements
- PhD or MS in chemistry, biochemistry, molecular biology, or chemical engineering with 7+ years of analytical development experience working in the Pharmaceutical or Biotechnology industry.
- Must have experience in developing, optimizing, troubleshooting, qualifying, and validating HPLC methods (SEC, RP, IEX, HIC etc.), for small molecules and/or large molecules characterization in cGMP environment.
- Hands on experience in analytical method development for ADC’s and small molecule linker payload including HPLC and mass spectrometry-based methods.
Physical Demands
- Stand for extended periods of time with periodic stooping/bending / kneeling.
- Able to lift, push, pull up to 50lbs.
- Work in a lab environment requires special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.
Working Conditions
Laboratory and Office environment
Certificates & Licenses Required
N/A
Compensation
$150,000- $170,000 per annum
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.
*We kindly request that agencies and recruiters do not contact us regarding this position.
QC Supervisor
Job Summary
The QC Supervisor is a hands-on laboratory position with additional supervisory and management responsibilities. The QC Supervisor will manage a group of QC scientists. The QC Supervisor 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. The QC Supervisor works cross-functionally with internal departments and external resources on QC related issues. This role supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Manage, coach, mentor, and lead a group of junior scientists.
- Schedule team work assignments based on project deadlines.
- Perform detailed peer review of analytical data to ensure accuracy.
- Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
- Work with management and vendors to acquire, install, and qualify new equipment.
- Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
- Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
- Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
- Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
- Conduct OOS, risk assessment, and root cause investigations and/or assist senior management with these investigations.
- Write deviations, change controls, and CAPAs, and/or assist senior management with these documents.
- Document work in laboratory notebooks and logbooks according to organizational GDP policies.
- Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
- Manage work outsourced to third-party analytical and metrology service providers.
- Performs other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Experience in leading people and projects.
- Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
- 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.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
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
Compensation
$90,000- $130,000 per annum
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.
*We kindly request that agencies and recruiters do not contact us regarding this position.
QC Scientist (I, II, III, IV)
Job Summary
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. The incumbent works cross-functionally with internal departments and external resources on QC related issues. The QC Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
- Work with management and vendors to acquire, install, and qualify new equipment.
- Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
- Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
- Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
- Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
- Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
- Write deviations, change controls, and CAPAs, and/or assist management with these documents.
- Document work in laboratory notebooks and logbooks according to organizational GDP policies.
- Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
- Manage work outsourced to third-party analytical and metrology service providers.
- Perform detailed peer review of analytical data to ensure accuracy.
- Perform other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Strong background in analytical sciences.
- Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
Job Specifications
Education and Experience Requirements
- BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
- 0-10 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
Office/ Laboratory position.
Certificates & Licenses Required
N/A
Compensation
$70,000- $110,000 per annum
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.
*We kindly request that agencies and recruiters do not contact us regarding this position.
QC Scientist (Senior/Principal)
Job Summary
The primary role of the Senior/ Principal 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. The incumbent works cross-functionally with internal departments and external resources on QC related issues. The Senior/ Principal QC Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
- Work with management and vendors to acquire, install, and qualify new equipment.
- Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
- Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
- Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
- Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
- Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
- Write deviations, change controls, and CAPAs, and/or assist management with these documents.
- Document work in laboratory notebooks and logbooks according to organizational GDP policies.
- Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
- Manage work outsourced to third-party analytical and metrology service providers.
- Perform detailed peer review of analytical data to ensure accuracy.
- Train and oversee junior scientists.
- Perform other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Strong background in analytical sciences.
- Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
Job Specifications
Education and Experience Requirements
- BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
- 10+ years of experience in a GMP manufacturing or CRO setting.
- Extensive knowledge of cGMP, FDA, EMA, ICH, USP, and Ph.Eur. guidelines
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
Office/ Laboratory position.
Certificates & Licenses Required
N/A
Compensation
$110,000- $150,000 per annum
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.
*We kindly request that agencies and recruiters do not contact us regarding this position.
Scientist, Analytical R&D
Job Summary
Under supervision 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. The incumbent works cross-functionally with internal departments and external resources on analytical research related issues. The Scientist, Analytical R&D supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Under supervision, 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.
- Apply routine and specialized analytical techniques to characterize and quantify small molecules such as linker payload and ADCs.
- Maintain reagent supplies, notebooks, summarize results in written reports and communicate observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting.
- Prepare high quality technical presentations and present internally and externally and participate in scientific discussions.
- Stays abreast of current literature in scientific areas
- Authoring analytical test methods, protocols, reports and other documents.
- Maintains lab equipment, orders supply for lab and provides general lab support.
- Perform other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Must have practical experience with some or all the analytical instruments such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (SQD, QQQ & QTOF), capillary electrophoresis and GC for method development.
- Experience with the application of separation, compendial, and spectroscopic techniques for the characterization of linker payloads and ADCs including HPLC (RP, SEC, HIC, IEX), gel and capillary electrophoresis (CE, cIEF).
- Must be able to handle complex data interpretation software and perform statistical analyses.
- Adhere to relevant regulatory guidelines for analytical method qualification/ validation and documentation, ensuring data integrity and compliance with ICH standards.
- Be able to work on multiple projects simultaneously upon being trained in analytical areas under the supervision
- A strong analytical and instrumental skills and a thorough understanding and working knowledge of analytical method development and validation.
- 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.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
- 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
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil business need.
Job Specifications
Education and Experience Requirements
- Ph.D. in Analytical Chemistry, organic Chemistry, Biochemistry or related areas with 0- 2 years industry experience
- M.S. in Analytical Chemistry, Organic Chemistry, Biochemistry, or related areas with 2-4 years industry experience
- More than 6 years of relevant experience with bachelor’s degree.
Physical Demands
N/A
Working Conditions
Office/ Laboratory position.
Certificates & Licenses Required
N/A
Compensation
$70,000- $110,000 per annum
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.
*We kindly request that agencies and recruiters do not contact us regarding this position.
Senior Scientist, Mass Spectrometry
Job Summary
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. The incumbent works cross-functionally with internal departments and external resources on analytical research related issues. The Sr. Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Develop and utilize advanced analytical tools, focusing on mass spectrometry and chromatography-based techniques to characterize mAb’s, proteins, peptides, oligos and ADCs facilitating critical decision-making
- Design and execute LC-MS/MS and LC-QTOF/MS workflows to characterize proteins, peptides, mAb’s and ADCs drug substances, and intermediates.
- Design and execute intact, reduced LC/MS, peptide mapping assays for ADCs characterization to support client projects
- Analyze and interpret complex datasets, providing insights to drive decision-making
- Stay at the forefront of technological advancements in mass spectrometry and other analytical technologies, integrating innovative solutions to enhance current workflows
- Participate in cross-functional project teams, contributing technical expertise to inform project strategies and directions
- Draft technical reports and contribute to scientific publications, patents, and regulatory submissions as necessary
- Mentor junior scientists in experimental design and data analysis to foster a collaborative and productive research environment
- Author analytical test methods, qualification protocols, reports, and other technical documents
- Act as an intellectual resource in the area of expertise by supporting assay troubleshooting, investigations, and improving analytical methods
- Play a key role in improving processes and procedures
- 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.
- Communicate effectively with supervisors, colleagues, clients, and vendors.
- Participates in scientific discussions; stays abreast of current literatures in scientific areas
- Performs other tasks and assignments as needed and specified by management
Required Knowledge, Skills, and Abilities
- Proven expertise in LC-MS (Waters QQQ, TOF & QTOF), Sciex (QQQ) and software platforms, including Mass Lynx, Empower & Analyst and Protein Metrics Suite, for intact mass deconvolution, peptide mapping analysis, post-translational modifications (PTMs), characterization of charge variants, and disulfide mapping
- Hands-on experience with a wide variety of analytical methods for protein characterization, including but not limited to LC-MS, LC-MS/MS, HIC, SEC, cIEF, IEX, CE-SDS, DLS and DSC.
- Experience in assay troubleshooting and optimization, with a strong understanding of assay development and execution
- Must be able to handle complex data interpretation software and perform statistical analyses
- 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.
- Must have knowledge of cGMPs specially with respect to analytical method transfer etc.
- Strong collaborative skills and ability to work effectively within multidisciplinary teams
- Excellent communication and presentation skills to convey technical information clearly and succinctly
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
- 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
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
- Must have at least 1 to 2 years GMP experience
Physical Demands
N/A
Working Conditions
Laboratory environment
Certificates & Licenses Required
N/A
Compensation
$110,000- $150,000 per annum
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.
*We kindly request that agencies and recruiters do not contact us regarding this position.
Senior/ Principal Scientist, Analytical R&D
Job Summary
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. The incumbent works cross-functionally with internal departments and external resources on analytical research related issues. He/she manages direct reports. The Senior/ Principal Scientist, Analytical supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Independently works on analytical method development, method optimization, troubleshooting, qualification, and validation in areas related to LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (QDa, QQQ, TOF, & QTOF), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
- Key aspect is taking a leadership role in proposing and implementing new platform technologies that increase analytical capabilities, improve process efficiencies, and mentor train and develop junior colleagues.
- Independently plans project responsibilities, executes activities against timelines, leads project scientific discussions
- Stays abreast of current literature in scientific areas
- Independently authors and reviews analytical test methods, protocols, and reports and other documents
- Liaises with purchasing to follow up on arrivals and help procurement with selection of materials
- Prepare and present project status and progress updates to client
- 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.
- Managers, coaches, and mentors direct reports.
- Perform other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Must have hands-on working experience and deep knowledge in analytical method development, optimization, troubleshooting, qualification, and validation of methods such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (QDa, QQQ, TOF & QTOF), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
- Work experience analyzing monoclonal antibodies (mAb’s), oligonucleotides, RNAs, and antibody drug conjugates (ADCs) is a huge plus.
- LC/MS method development for characterization of mAb’s, ADC and Oligo-antibody conjugates is plus.
- Working experience on control strategies for large molecules for DS and DP, phase appropriate national and international regulatory filing strategies.
- Able to develop and execute independently and/or collaboratively all aspects of analytical methods to support bio-conjugation team, process development, product development, in-process monitoring, stability studies for APIs/drug substances/bioconjugates including authoring and reviewing analytical methods, protocols, and reports for clients and stakeholders
- Be a Subject Matter Expert for the team and support assay troubleshooting, investigations, and improving analytical methods and interpret complex data and perform statistical analysis using appropriate software
- Ability to take on a leadership role and be strategic in proposing new technologies to improve process efficiency and increase capabilities
- Plan and execute work on multiple projects simultaneously by collaborating with Chemistry, Bioconjugation, Process Development, Project Management and NJ Bio’s clients on clinical stage APIs/ADCs
- Exhibit strong departmental leadership for best practices of technique, instrumentation, regulatory strategy, project management, processes, information organization, and communication
- Prior experience with training.
- 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
- Communicate effectively with supervisors, colleagues, clients, and vendors.
- Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
- 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
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil business need.
Job Specifications
Education and Experience Requirements
- Ph.D. in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas with over 5 – 7 years for Principal Scientist and 2 – 4 years for Senior Scientist
- Proven track record of industry experience.
- Proven track record in analytical method development, project leadership and problem solving in the pharmaceutical or biotech industry
- Must have at least 2 years of GMP experience.
Physical Demands
N/A
Working Conditions
Office/ Laboratory environment
Certificates & Licenses Required
N/A
Compensation
$110,000- $150,000 per annum
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 Operations
No Open Roles At This Time
R&D - Chemistry & Process Development - Biocon & Chemistry
*We kindly request that agencies and recruiters do not contact us regarding this position.
Scientist, Chemistry
Job Summary
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.
The incumbent works cross-functionally with internal departments and external resources on research and development related issues. The Scientist, Chemistry supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Plan and execute chemical syntheses from milligrams to hundreds of grams scales.
- Conduct purification and characterization of compounds.
- Carry out literature searches using chemical program databases (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 tasks and assignments as needed and specified by management.
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.
- Demonstrate a willingness for continued learning.
- Maintain a culture of safety within the lab and ensure safe work practices are followed.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfill the business need.
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.
- Experience working in a Kilo-lab and pilot plant is a plus
Physical Demands
Occasionally required to lift or move objects up to 40lbs
Working Conditions
On-site only, in laboratory majority of time and in office
Certificates & Licenses Required
N/A
Compensation
$85,000- $90,000 per annum
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.
Bioconjugation
No Open Roles At This Time
Operations
*We kindly request that agencies and recruiters do not contact us regarding this position.
Manufacturing Associate I
Job Summary
The Manufacturing Associate I is responsible for the execution of production activities for early phase small molecule and/or biological programs within a GMP environment. The incumbent works cross-functionally with internal departments and external resources on manufacturing related issues. The Manufacturing Associate I supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
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.
- Assists in biomanufacturing production of biologics, as well as assisting with bioconjugation processes used in the manufacture of biologic drug substances such as mRNA therapeutics and Bioconjugates (ADCs, Oligoconjugates, etc.).
- 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 set-up, 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
- Performs other tasks and assignments as needed and specified by management
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.
- Energetic, motivated and dynamic individual.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
Job Specifications
Education and Experience Requirements
- BA/BS degree in a scientific discipline (synthetic /organic chemistry)
- 0-2 years of cGMP experience.
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
Compensation
$20- $25 per hour
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.
Assistant Project Manager
Job Summary
We are looking for a dedicated and detail-oriented Assistant Project Manager to join our team. The successful candidate will be responsible for supporting project management activities, ensuring projects are completed on time, within scope, and on budget, while maintaining high levels of customer satisfaction and collaboration. This position requires it to be onsite the vast majority of the time. The incumbent works cross-functionally with internal departments and external resources on project management related issues. The Assistant Project Manager supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Communicate with external clients and internal stakeholders, coordinate meetings, conduct meetings, record meeting minutes, and organize and store meeting files and documents in designated locations.
- Develop and manage a detailed project schedule and work plan, tracking project scope, timelines, status, and budget to ensure on-time and on-budget delivery of projects. Adjust timelines as needed.
- Keep clients and project teams updated with progress reports and up-to-date information on the project.
- Collaborate with the GMP teams and contribute to their activities as needed.
- Partner with management to support safety and quality initiatives within the organization.
- Utilize industry best practices, techniques, and standards throughout the entire project execution.
- Develop and maintain strong collaborative working relationships and interact effectively with all levels within the organization and with external clients.
- In emergency cases (During GMP operations), the employee is expected to be available virtually or in some cases onsite, during holidays, weekends, and early/late hours.
- Perform other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Outstanding interpersonal skills with a demonstrated ability to effectively build positive working relationships across functions.
- Well-versed in basic project management principles, including identifying critical paths, building and communicating timelines, defining milestones, and setting expectations and accountability.
- Self-motivated with a willingness to grow and learn new skills.
- Proficiency in MS Project is recommended.
- Proficiency in using Smartsheet for project management is a plus.
- May occasionally require working beyond regular business hours to accommodate international clients.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
Job Specifications
Education and Experience Requirements
- BS, MS, or PhD in Chemistry, Biochemistry, Biology, Health Sciences, or other related disciplines is a plus.
- 0-2 years of experience in project management in the pharmaceutical/ biotechnology field.
- GMP Planning, Facilities, Engineering, Metrology, and QC experience is a plus.
- Experience with Change control, CAPA, Deviation, Commission and Qualification is a plus.
- PMP Certificate is a plus.
- Smartsheet experience is a plus.
Physical Demands
N/A
Working Conditions
Office based position.
Certificates & Licenses Required
PMP Certificate is a plus
Compensation
$65,000- $68,000 per annum
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 & GMP Manufacturing Chemist III
Job Summary
Works on multiple steps/multiple projects to execute chemical syntheses from mgs to grams to kilo scales and conduct pilot scale synthesis (kilo scale), purification and characterization of compounds and present results and progress updates to internal and external stakeholders, maintain and clean ab equipment, ensure GMP room maintenance, MBR writing, and perform manufacturing-related activities. The candidate works cross-functionally with internal departments and external resources on process development and GMP manufacturing related issues. The Process & GMP Manufacturing Chemist III supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Should be flexible with small scale and manufacturing execution.
- Perform hands-on laboratory chemical development of robust, safe, and scalable processes for operation in Kilo-lab, pilot plant and GMP suite.
- Participate regularly in cross functional project teams within Research and Development and with external clients as needed (on mg to multi-gram scale projects).
- Works on kilo-lab equipment to prepare pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs) under supervision until fully trained.
- Applies technical knowledge to safely execute synthetic organic chemistry processes for scale up into large glassware, supports and works on pilot plant tech transfers projects for APIs, and HPAPIs.
- Maintain GMP lab equipment and instruments, MBR writing/review and execution plan.
- Documentation of deviations & CAPAs.
- Maintain GMP room status and cleanliness
- Performs pilot scale purifications using Teledyne ISCO purification and Torrent system
- Performs GMP manufacturing of small molecules/ nucleic acids/ antibody conjugate.
- Perform 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 work on synthetic organic chemistry processes for scale up of APIs, HPAPIs at pilot scale is needed.
- Good interpersonal skills to be an effective member of a multi-disciplinary team 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, deviations, CAPA and regulatory environment.
- Well versed with GMP lab equipment and instruments.
- Be able to organize work efficiently such that several operations can be carried out simultaneously.
- Ability to be a collaborative team member.
- Ability to apply critical thinking and have good problem-solving skills.
- Demonstrates a willingness to learn and work proactively.
- Able to communicate scientific data effectively through presentations, notebooks, and reports.
- 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.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil business need.
Job Specifications
Education and Experience Requirements
- PhD/MS/BS level in Organic Chemistry with at least 6 years of industry experience in pharmaceutical process development for scale up of intermediates and APIs into Kilo-lab, pilot plant and GMP facilities
- 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
Physical Demands
- Ability to work in a cleanroom environment, adhering to strict safety and cleanliness protocols.
- Ability to lift and carry materials up to 30 lbs and perform tasks that may require standing for extended periods.
- Must be willing to work 10-hour shifts using PPEs including PAPRs and must be gowned when inside process suite.
- Physical dexterity sufficient to use pipettes, laboratory equipment, computers and documentation.
- Sufficient vision and hearing capability to work in job environment.
- Must have the ability to work in laboratories and controlled, enclosed, restricted areas.
- Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet including PAPRs
- Jewellery, makeup, gum, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.
- Flexibility to don clean room garments and personal protective equipment (PPE) and PAPRs.
- The manufacturing environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
- Reagents, chemicals, and exposure to sanitization agents are expected.
- Restricted areas prohibit food, any outside materials such as cell phones, tablets, at a minimum.
Working Conditions
This role will primarily be based in the GMP manufacturing facility, with periodic office-based work for
reporting and cross-functional collaboration.
Additional Information
- This position may require shift work, weekend or holiday hours, or on-call responsibilities depending on the production schedule.
- Training in GMP will be provided as needed.
- The company offers competitive benefits, including health insurance, retirement plans, and paid time off.
Certificates & Licenses Required
N/A
Compensation
$100,000- $110,000 per annum
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.
Materials Management Specialist
Job Summary
This role is required to purchase materials, consumables, and supplies for R&D, GMP Manufacturing and Process Development. The incumbent works cross-functionally with internal departments and external resources on materials management related issues. The Materials Management Specialist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
General warehouse –
- Source raw materials and consumables from vendors
- Receipt of incoming deliveries and storing under recommended conditions following site procedures.
- When applicable, assigning the material into ChemInventory system to proper personnel.
- Barcoding material container when applicable or providing barcodes with material to scientist to apply.
- Maintaining clean and neat warehouse
- Track orders daily. Contact vendors for issues.
- Collecting completed documents from shipments and storing per site procedure
- Shipping materials via courier companies
- Ensuring label/customs/SDS/other documentation for shipping
- Ensure proper packing of material, proper temperature requirements are met, communication is sent to outgoing requestor / recipient, and preparation of packing list / commercial invoice. Confirm delivery and notify outgoing requestor.
GMP Warehouse –
- Work with GMP manufacturing and PD to order materials.
- Future: Kitting, dispensing and quarantining chemicals.
- Draft specs, gather documents as CoA, BSE/TSE and SDS.
- Confirming receipt of material in appropriate system following GMP receiving procedures to distribution. Receipt includes confirmation that the material(s) have arrived correct, intact, and not tampered with. Removal of most materials from delivery packaging unless the material is packed under specific temperature requirement (dry ice, etc.)
- Organize GMP and R&D items in warehouse and solvent rooms.
- Support GMP equipment orders as needed.
- Maintain updated list of consumables/materials for assets in GMP.
- Inventory maintenance. Constant monitoring of general stock items. Reordering when needed.
- Keeping copies of Safety Data Sheets in binders and also in ChemInventory.
SAP/Ariba –
- Daily monitoring of SAP/Ariba system including approving orders $5,000 or less, ensuring general supply orders are not being placed without reason, following up on backorder items and communicating info to ordering personnel. Completing purchases for personnel via direct order.
- Weekly tracking materials not arrived yet in SAP/Ariba.
- If requested also tracking orders not listed in SAP/Ariba.
- Invoice entry for Cintas, WB Mason and for other vendors as needed.
- Backup for invoice entry as needed.
Other –
- Maintaining a neat, safe working environment.
- Import documentation. Maintaining all import documents for each shipment from NJBIO India.
- Escort garment vendor, document shredding, and dry ice vendor into the building for service. Ordering new lab coats for new employees from garment vendor.
- Dry ice ordering
- Backup for Quarterly inspections of safety showers / eyewashes only if lab specialist and facility superintendent out of office when needed.
- Ensure materials are being refilled in general areas when lab specialist is unavailable.
- Order materials that lab specialist requests for general area supplies.
- Backup for Ordering group lunches and lunches for client meetings and general office supplies.
- Checking mail and distribution daily.
- Assist Materials manager with invoice matching, getting quotes, and sending POs when needed.
- Perform other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Experience with the SAP/Ariba procurement system.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as required to fulfill business needs.
Job Specifications
Education and Experience Requirements
- Associate degree in Chemistry/ Biology with 3-5 years of experience in Materials Management.
- Bachelor’s degree in Chemistry/ Biology with 1-3 years of experience in Materials Management.
Physical Demands
Ability to lift up to 60 lbs. No restrictions on standing and walking for long periods.
Working Conditions
Office, laboratory and manufacturing environment
Certificates & Licenses Required
N/A
Compensation
$60,000- $80,000 per annum
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 I/II/III, Biological Operations
Job Summary
We are seeking a highly motivated and skilled Manufacturing Associate, Biological Operations in a cutting-edge biomanufacturing facility focused on bioconjugation and the production of mRNA-based therapies. The Manufacturing Associate will play a critical role in ensuring the aseptic processing, and production of biologics, as well as assisting with bioconjugation processes used in the manufacture of biologic drug substances such as mRNA therapeutics and Bioconjugates (ADCs, Oligoconjugates, etc.). This role requires experience in manufacturing techniques, including a strong understanding of aseptic and low bioburden bioprocessing principles, and the ability to work effectively in a team-oriented, GMP-compliant environment. ensuring compliance with Good Manufacturing Practices (GMP), and contributing to a high-quality, efficient production process. Associates in this role will collaborate with other team members to ensure timely and accurate production while adhering to strict safety and regulatory guidelines.
The incumbent works cross-functionally with internal departments and external resources on manufacturing related issues. The Manufacturing Associate supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
Manufacturing Operations –
- Operate, monitor, and maintain aseptic and low bioburden manufacturing equipment (e.g., filling lines, bioreactors, filtration systems (TFFs, aseptic filtration, etc.), purification systems (AKTA) etc. to ensure consistent and compliant production of bioconjugated products and mRNAs.
- Prepare and execute standard operating procedures (SOPs) for aseptic processing, including formulation, filling, and capping.
- Maintain the sterile environment, including monitoring of environmental conditions and performing critical interventions to ensure sterility.
- Assist in the preparation, sterilization, and maintenance of components such as bioreactor bags, filters, and other disposables.
Bioconjugation Support –
- Assist in the production and conjugation of biologic molecules, such as ADCs or other biomolecules such as oligoconjugates, mRNAs or other biotherapeutic molecules (drug substance).
- Involved in preparation of reagents and buffers, pack columns as needed.
- Help monitor critical process parameters (CPPs) during the conjugation steps to ensure product quality.
mRNA Manufacturing Support –
- Perform operations related to the synthesis, purification, and formulation of mRNA, including the preparation of reagents, buffers, and solutions.
- Assist in the execution of mRNA transcription and purification processes in a cGMP-compliant environment.
- Perform routine IPC testing of mRNA products to ensure quality and consistency.
Documentation and Compliance –
- Complete batch records and documentation in accordance with GMP standards and regulatory requirements.
- Assist in investigating and documenting any deviations and participate in CAPA (Corrective and Preventive Action) investigations.
- Maintain accurate records of production activities, ensuring all documentation is completed in a timely and compliant manner.
- Ensure that all manufacturing operations are performed in accordance with company SOPs, GMP, and safety standards. Report any deviations or quality issues to management and assist in investigations.
Equipment Maintenance and Troubleshooting –
- Support troubleshooting of equipment malfunctions and coordinate with maintenance personnel to ensure minimal downtime.
- Perform routine maintenance and calibration of aseptic equipment.
- Participate in equipment qualifications as needed.
Collaboration and Communication –
- Collaborate with cross-functional teams, including Quality Control (QC), Quality Assurance (QA), Tech Operations, and Engineering, to ensure smooth operation, meeting project timelines, and compliance.
- Actively participate in team meetings, contributing to process improvements and safety discussions.
Environmental Monitoring –
- Participate in environmental monitoring activities, including monitoring air quality, clean room conditions, particulate counts, and maintaining compliance with environmental controls.
- Cleaning of the rooms used in production and documentation of cleaning to maintain compliance with regulatory standards.
- Supervising vendors for cleaning or sampling for microbial testing
Training –
- Participate in ongoing training programs to stay current with best practices in aseptic operations, equipment handling, and regulatory requirements.
• Performs other tasks and assignments as needed and specified by management
Required Knowledge, Skills, and Abilities
- Strong technical and troubleshooting skills.
- Ability to work in a fast-paced environment and manage multiple priorities.
- Strong attention to detail and commitment to maintaining high-quality standards.
- Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements (FDA, OSHA, etc.).
- Experience with aseptic technique and sterile processing procedures.
- Ability to operate and troubleshoot manufacturing equipment in a regulated environment.
- Basic computer skills, including experience with electronic batch records and data entry.
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
- Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
Job Specifications
Education and Experience Requirements
- Associate’s or Bachelor’s degree in Biological Sciences, Biotechnology, Bioengineering, or related field. High School Diploma or GED required; Associate’s Degree or higher in a related field (e.g., Life Sciences, Engineering, or Biotechnology) preferred.
- Minimum of 2 years of experience in aseptic manufacturing, bioconjugated products, or mRNA production.
- Experience with bioconjugation processes and/or mRNA technologies is a significant plus.
- Knowledge of cGMP (current Good Manufacturing Practices) and regulatory requirements.
- Familiarity with bioreactor operations, aseptic techniques, purification techniques, and sterile filling operations.
- Familiarity with quality control testing methods for bioconjugated and mRNA products preferred.
- Knowledge of automation systems for aseptic and low bioburden manufacturing preferred.
- Experience with process monitoring and data analysis tools preferred.
Physical Demands
- Ability to work in cleanroom environments for extended periods.
- Ability to lift up to 30 lbs.
- Ability to stand for extended periods and perform repetitive tasks.
- Must be willing to work 10-hour shifts using PPEs including PAPRs and must gown when inside process suite.
Working Conditions
This position is based in a manufacturing environment with a focus on aseptic and low bioburden processing in a cGMP-regulated facility. The Manufacturing Associate will work in cleanroom conditions, adhering to all safety, cleanliness, and protocol standards to ensure the highest product quality.
Certificates & Licenses Required
N/A
Compensation
$20- $40 per hour (based on level)
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
Finance & IT
Accountant
Job Summary
We are looking for a dedicated and detail-oriented Accountant to join our team. The successful candidate will be responsible for supporting financial reporting, audits, tax and compliance related activities. The incumbent works cross-functionally with internal departments and external resources on accounts and finance related issues. The Accountant supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Preparation of monthly, quarterly and annual financial statements as per the Financial reporting framework
- Assisting in audits / reviews / diligence as may be mandated under various laws
- Prepare financial MIS reports for the management
- Ensuring completeness and accuracy of book keeping and financial records being maintained
- Prepare various reconciliations keep updated schedules for the data reflecting in the accounting software
- Timely submission of accounts to Tax Advisors for Estimated tax evaluation and annual tax return filing
- Assist in timely preparation of monthly customer invoices and tracking receivables
- Maintaining and updating the Fixed Asset Register
- Assist in consolidation of financial statements and keeping financial data updated from various subsidiaries
- Assist in preparation of operational cash flow and reconcile vendor and customer ledgers
- Provide data & reports requested by the management team from time to time
- Perform other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Proficiency in preparing reports as per the financial framework
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills as well as interpersonal skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- 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.
Job Specifications
Education and Experience Requirements
- Degree in Finance/ Accounting with 5+ years of relevant experience.
- Prior experience of working on SAP platform would be an added advantage.
Physical Demands
N/A
Working Conditions
Office based position.
Certificates & Licenses Required
N/A
Compensation
$65,000- $75,000 per annum
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.
Human Resources
No Open Roles At This Time
Platform Innovation
No Open Roles At This Time
In vivo and Translational
Vice President, Translational Research
Job Summary
Vice President, Translational Research leads the strategic integration of preclinical research functions that bridge discovery and clinical readiness, with a focus on ADCs, biologics, and complex therapeutic platforms. This role encompasses scientific leadership, operational oversight, and regulatory alignment across chemistry synthesis and in vivo pharmacology. This role is directly responsible for the direction and output of the Bristol, PA in vivo research facility, ensuring high quality experiment design, regulatory compliance (GLP compliance, DEA, IACUC, AAALAC). A key part of their function includes building IND-enabling packages and contributing to regulatory strategy and FDA communications, including authorship and active participation in pre-IND meetings and briefing responses. He/ she manages direct reports. The incumbent works cross-functionally with internal departments and external resources on preclinical research related issues. The VP, Translational Research is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Responsibilities
- Responsible for the direction and output of the Bristol, PA in vivo research facility, ensuring scientific rigor, regulatory compliance (GLP, IACUC, AAALAC), and high-quality data generation in all animal studies.
- Oversee scientific and operational management of the L2P/Bristol animal research facility, including model development, study design, IACUC oversight, and team mentorship.
- Ensure DEA compliance across all controlled substance activities, including procurement, handling, storage, documentation, and reporting.
- Evaluate and expand in vivo capabilities in alignment with NJ Bio’s evolving scientific portfolio and service offerings.
- Establish ADC PK/PD safety and efficacy modeling using established custom in-vivo systems
- Lead the design and execution of translational research strategies across in vivo pharmacology and mechanistic studies for ADCs and targeted biologics.
- Build and refine IND-enabling study packages, collaborating with regulatory, bioanalytical, and quality teams to support regulatory submissions.
- Coordinate cross-functionally with chemistry, conjugation and CMC to ensure data-driven decision-making in compound selection and IND-readiness.
- Coordinate study development efforts to measure target engagement and pharmacologic effect, ensuring relevance to clinical translation.
- Represent the translational function in internal strategy discussions, client meetings, and regulatory communications, with scientific accountability for pharmacology content.
- Perform other tasks and assignments as needed and specified by management.
Required Knowledge, Skills, and Abilities
- Ability to influence without direct authority.
- Demonstrated leadership ability and experience managing, coaching and mentoring direct reports
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
- 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.
Job Specifications
Education and Experience Requirements
- Ph.D. in Biology, Biochemistry or related translational field with 10+ years of industrial experience with at least 5+ years of managing teams.
- Extensive work with animal models in oncology.
- Direct experience of maintaining, training new employees and leading an animal facility.
- Strict adherence to animal welfare standards, procedures and committees.
- Experienced in obtaining and maintaining relevant approvals and permits (i.e. DEA, AALAC, etc).
Physical Demands
Handling animals, standing position, lifting cages (<40 lbs)
Working Conditions
Office and laboratory environment
Certificates & Licenses Required
N/A
Compensation
$160,000 to 180,000 per annum
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.
Other
No Open Roles At This Time
Life Sciences Talent Connection Day Attendees
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.