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QA Specialist III

Job Summary

The QA Specialist III will support clinical manufacturing operations. This individual will provide oversight of manufacturing activities from a quality perspective with limited supervision.

The incumbent works cross-functionally with internal departments and external resources on QA related issues. The QA Specialist III supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• 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 Chain 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.
• Support and Participate in Self-Inspections, Internal and External Audits.
• Provide training and guidance to other departments on GMP, Data Integrity and general Compliance aspects.
• Provide oversight on Event Reports, including Deviations and Investigations, and follow up to closure.
• Perform Document Control Tasks, on paper and electronic documents; including issuance of logbooks.
• 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. This task will occasionally require overnight and/or weekend work.
• Support Quality Management Systems (ie. Master Control) in both performing QA tasks using these systems (document control, procedure review/approval, supplier qualification, etc) and also in managing such systems.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Able to handle multiple client projects for Quality requirements.
• Ability to write and present reports/investigations and host meetings to support Quality Systems
• Ability to train employees in a small group setting.
• Experience with Master Control (electronic documentation system) or similar QMS (ie. 1QEM) is preferable.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
• 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

• 2-4 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.

Physical Demands

Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Working Conditions

Office/ Laboratory position.

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

Bioassay Intern

Job Summary

The Bioassay Intern provides support to the Bioconjugation team in day-to-day activities as needed. The incumbent supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Perform basic cell culture work which will include mammalian cell culture, plating and cytotoxicity testing.
• Documenting all research activities and maintaining a detailed laboratory notebook.
• Perform data analysis, and related document writing with a critical look at the relevance of the results.
• Summarize and communicate the progress of the work.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Ability to learn fast, absorb knowledge, and apply newly learned information daily.
• Possess an upbeat attitude with the desire to learn new skills
• Self-motivated with the ability to engage in independent work to increase job related knowledge and skills
• Ability to discreetly handle sensitive and confidential material.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint).
• 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

• Undergrad with some knowledge of cell biology & molecular biology.
• Basic understanding of computer skills including MSOffice (Excel, Powerpoint & Word).
• Ready to use GraphPad prism.

Physical Demands

Standing/ sitting long periods of time

Working Conditions

On-site full-time; Office/ laboratory environment at our Princeton, NJ location.

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.

Bioconjugation Intern

Job Summary

The Bioconjugation Intern provides support to the Bioconjugation team in day-to-day activities as needed. The incumbent supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Perform basic bioconjugation work which will include conjugation, analysis, and purification.
• Documenting all research activities and maintaining a detailed laboratory notebook.
• Perform data analysis, and related document writing with a critical look at the relevance of the results.
• Summarize and communicate the progress of the work.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Ability to learn fast, absorb knowledge, and apply newly learned information daily.
• Possess an upbeat attitude with the desire to learn new skills
• Self-motivated with the ability to engage in independent work to increase job related knowledge and skills.
• Ability to discreetly handle sensitive and confidential material.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint).
• 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

• Undergrad with some knowledge of organic chemistry.
• Basic understanding of computer skills including MSOffice (Excel, Powerpoint & Word)

Physical Demands

Standing/ sitting long periods of time

Working Conditions

On-site full-time; Office/ laboratory environment at our Princeton, NJ location.

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.

VP, Manufacturing/ Technical Operations

Job Summary

The Vice President, Manufacturing/ Technical Operations (MTO) will be responsible for developing NJ Bio’s strategic manufacturing/technical start-up operations roadmap, which also includes activities that support Good Manufacturing Practices (GMP). These activities include production operations, facility, capital engineering (commissioning, equipment, facility buildout/expansion), process engineering (manufacturing sciences and technology (MSAT), qualification/validation, technical operations, EHS, and warehouse management and maintenance. This individual will engage and develop the MTO team and explore technical partnerships with academic and other organizations/institutions to stay at the forefront of manufacturing technologies. The candidate is expected to roll up their sleeves to perform or implement policies, procedures and strategies as required by operations. The incumbent works cross-functionally with internal departments and external resources on manufacturing/ technical operations related issues. The VP, Manufacturing/ Technical Operations accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Lead, develop, implement, and execute a global manufacturing strategy that is aligned with NJ Bio’s expectations to provide high-quality clinical supplies to clients.
• Build, develop, and lead a department that has the capability to manufacture multiple active pharmaceutical products (API) including high-potent APIs (HPAPI), mRNAs, drug substances (DS), and Antibody Drug Conjugates (ADCs) following GMP standards.
• Oversee, and as required, perform and implement all the activities that support the manufacturing of GMP materials such as facility, capital engineering (commissioning, equipment, facility buildout/expansion), process engineering (manufacturing sciences and technology (MSAT), qualification/validation, master validation plan, warehouse management and maintenance.
• Oversee/implement the department’s finalization of manufacturing campaigns and engineering projects.
• Develop short- and long-term technical objectives for the organization that cover manufacturing and engineering.
• 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.
• Contribute to evaluating customer/partnership at an early stage.
• Work with senior leadership to evaluate customers/clients and recommend decision on manufacturing capability and assist in pricing for services.
• Serve as the technical (manufacturing and engineering) lead for manufacturing partnerships/collaboration.
• Serve as the technical operations (manufacturing and engineering) due diligence lead for business development activities.
• 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.
• Maintain the operational facility at a high level of cGMP compliance per FDA, EMEA and customer expectations.
• Ensure that all operations are always compliant with EHS Standards and OSHA and EPA requirements.
• Promote and ensure a safety culture with areas of responsibility.
• Manage, coach, and mentor direct reports.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Strong background in manufacturing multiple active pharmaceutical and biologic products (API) including high-potent APIs (HPAPI), mRNAs, drug substances (DS), and Antibody Drug Conjugates (ADCs)
• Hands-on experience working in GMP environment and clinical manufacturing
• Leadership experience of teams is required.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Ability to influence without direct authority
• 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, engineering or related discipline.
• 10 years of experience in a GMP manufacturing or CRO setting and leadership experience required.

Physical Demands

• Requires standing and walking.
• Occasionally requires lifting of up to 20 pounds.
• Requires manual dexterity and visual abilities.

Working Conditions

Office based position with ability to occasionally work in laboratory.

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-IV

Job Summary

The Manufacturing Associate II-IV 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 II-IV 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.
• Involved in biomanufacturing production of biologics, as well as 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.
• May be asked to perform experiments for process development under supervision of senior personnel
• 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 with accompanying recovery studies.
• 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
• Senior level may be involved in training associates I and II.
• 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/ Bioengineering/ Biochemistry/ equivalent)
• 2-11 years of cGMP experience.
• Strong desired background in science, technology, and manufacturing.
• Experience in HPAPI a plus.

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.

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.
• 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

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

Protein Production Intern

Job Summary

The Protein Production Intern provides support to the Platform Innovation team in day-to-day activities as needed. The incumbent supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Perform basic recombinant protein expression and purification, which will include bacterial cell culture, FPLC operation for affinity and ion exchange chromatography, SDS PAGE purity assessments, and other activities.
• Documenting all research activities and maintaining a detailed laboratory notebook.
• Perform data analysis, and related document writing with a critical look at the relevance of the results.
• Summarize and communicate the progress of the work.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Ability to learn fast, absorb knowledge, and apply newly learned information daily.
• Possess an upbeat attitude with the desire to learn new skills
• Self-motivated with the ability to engage in independent work to increase job related knowledge and skills
• Ability to discreetly handle sensitive and confidential material.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint).
• 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

• Undergrad with some knowledge of biochemistry & molecular biology.
• Basic understanding of computer skills including MSOffice (Excel, Powerpoint & Word)
• Ready to use GraphPad prism

Physical Demands

Standing/ sitting long periods of time

Working Conditions

On-site full-time; Office/ laboratory environment at our Princeton, NJ location.

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

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