NJ Bio, Inc._Careers

Careers

World ADC Best Contract Research Provider 2023

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

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

R&D - Bioconjugation

No Open Roles At This Time

 

R&D - Oligonucleotide Conjugation

No Open Roles At This Time

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

No Open Roles At This Time

R&D - Chemistry

No Open Roles At This Time

R&D - Project Management

No Open Roles At This Time

R&D - Process Development, Bioconjugation

No Open Roles At This Time

Manufacturing

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

Manufacturing Associate I/II for Clinical Manufacturing (Phase 1 and Phase 2) 

The Manufacturing Associate I/II for Clinical Manufacturing (Phase 1 and Phase 2) is responsible for the execution of production activities for early phase small molecule and/or biological programs within a GMP environment.

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


Qualifications:

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


Job Specifications

Education and Experience Requirements

  • High School Diploma / associate degree with exposure to science & math coursework or BA/BS degree in a scientific discipline (synthetic /organic chemistry)
  • About 2 years of cGMP experience for BA/BS degree holders or 3-5 years’ experience for diploma/associate degree holders.
  • Strong desired background in science, technology, and manufacturing.


Physical Demands

Ability to lift up to 20kg

Working Conditions
Lab/manufacturing environment

Certificates & Licenses Required
N/A

 

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Senior Manufacturing Associate 

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

Job Responsibilities

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


Required Knowledge, Skills, and Abilities

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


Job Specifications

Education and Experience Requirements

  • High School Diploma / associate degree with exposure to science & math coursework
  • BA/BS degree in a scientific discipline (life sciences / engineering / (synthetic /organic chemistry)– Preferred
  • 5-10 years of cGMP experience


Physical Demands

Ability to lift up to 20kg

Working Conditions
Lab/manufacturing environment

Certificates & Licenses Required
N/A

 

Confirm Job Qualifier To Apply


 

MSAT/Process Engineer – Various Levels

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

Key Responsibilities

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


Required Knowledge, Skills, and Abilities

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


Job Specifications

Education and Experience Requirements

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

Physical Demands
N/A

Working Conditions
Office environment with some lab/manufacturing environment

Certificates & Licenses Required
N/A

 

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AD/Director Small Molecule Manufacturing

Job Summary

The following is a job summary of the associate director/director of Small Molecule Manufacturing:

  • Plan and execute daily activities in a multi-product clinical manufacturing facility.
  • Adopt small-scale models constructed during process development and test at large scale via pilot-scale production in manufacturing to determine whether production models are scalable.
  • Coordinate the support of internal and external resources to accomplish production goals with minimal oversight.
  • Oversee manufacturing supervisors, leads chemists and technicians including training, daily assignments and perform document reviews and owning deviations and change controls where applicable.
  • Provide direction and hands-on training for staff.
  • Collaborate with cross-functional teams to resolve technical and logistical challenges e.g. process development, process transfer and supply chain.
  • Foster an environment of safety, quality compliance, strong work ethic and ongoing learning.
  • Lead projects related to continuous improvement, operational readiness, and campaign startup/close out during non-production periods and support activities including non-clinical development runs, recipe programming and testing, and maintenance / qualification / calibration.

 

Note: The position may require off-hour support as needed. Work may include weekends, off hours and holidays.

Key Responsibilities

  • Oversee manufacturing operations, suite and team by coordinating and monitoring activities.
  • Provide necessary program direction (tracking and reporting tools) for planning, organizing, developing, and integrating projects across multiple functional areas.
  • Mentor and manage a growing team of supervisors, chemists, and technicians.
  • Hands-on lead in troubleshooting efforts related to processing and process equipment problems.
  • Writes and/or reviews MBR’s, SOP’s, and other technical documents.
  • Ensures operations are in compliance with all Regulatory, EHS, and cGMP quality systems that assure proper design, monitoring, and control of manufacturing processes and suite.
  • Manages the raw material needs, production schedules, finished product inventories and logistics of shipments.
  • Evaluate and implement new technologies as needed.
  • Reporting of KPIs, operational metrics and project updates to SLT.
  • Act as a change agent to implement necessary manufacturing suite improvements as dictated by business needs.
  • Produce key operations deliverables including URS’s, commissioning, start-up, and operator training.
  • Maintain Quality System and GMP training requirements.
  • Collaborates with the EHS group on environmental, health and safety-related aspects of all operations.
  • Participation in multidisciplinary alignment meetings, safety, and quality risk assessments
  • Effectively partner with diverse internal stakeholders (process chemistry, analytical development, quality assurance, regulatory affairs, manufacturing science and technology, supply chain, quality control, facilities, and manufacturing operators) to build robust processes and supporting resources.

 

Required Knowledge, Skills, and Abilities

  • Experience in small molecule chemistry and/or manufacturing preferred.
  • >5 years management level experience with ability to develop staff.
  • Excellent interpersonal and communication skills
  • Ability to influence stakeholders and drive decision-making.
  • Proficient in MS Office Software such as Excel, Word, Outlook and PowerPoint.
  • Experience in MasterControl eQMS and eBR is a plus.
  • Experience in Unicorn, Opti-Dry, Rockwell Studio is a plus.
  • Knowledge of chemical engineering principles including reaction kinetics, reactor design, chemical thermodynamics, process modeling, heat, and mass transport a plus.
  • Business acumen including experience with Asana, Smartsheet or Microsoft project or equivalent management tool and proven ability to learn and adapt to new systems
  • Understanding and/or experience in chemical process scale-up and manufacturing of pharmaceuticals
  • Proven record of calm under pressure and a positive attitude.
  • Highly organized.
  • Ability to effectively collaborate.
  • Outstanding communication skills (verbal and written).

 

Job Specifications

Education and Experience Requirements

Minimum of a Bachelor of Science (BS) in Chemical Engineering, Organic Chemistry, Process Chemistry or Physical Chemistry and a minimum of 10 years of experience within Pharmaceutical or CDMO industries. GMP experience a plus.

Physical Demands
N/A

Working Conditions
Office environment with some lab/manufacturing environment

Certificates & Licenses Required
N/A

 

 

 Confirm Job Qualifier To Apply

 

Process R&D

No Open Roles At This Time

Quality Control

QC Scientist (I, II, III, IV)

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 and document the results under GMP settings.
  • 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 of analytical protocols & reports for method transfers, qualification, 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.

 

Skills

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

 

Education and Experience

  • Scientist I – BS with 0 years of relevant experience in GMP/CRO setting, MS or higher degree with at least 1 year of relevant experience in GMP/CRO setting, or equivalent combination of work experience, education, and training
  • Scientist II – BS with at least 2 years of relevant experience in GMP/CRO setting, MS or higher degree with at least 0 years of relevant experience, or equivalent combination of work experience, education, and training
  • Scientist III -BS with at least 3 years of relevant experience in GMP/CRO setting, MS or higher degree with at least 2 years of relevant experience, or equivalent combination of work experience, education, and training
  • Scientist IV- BS with at least 4 years of relevant experience, MS or higher degree with at least 3 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

 

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QC Scientist (Senior and Principal Scientist)

Responsibilities:

  • Independently 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 and document the results under GMP settings.
  • 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, qualification, 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.

 

Skills

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

 

Education and Experience

  • BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
  • For Senior Scientist – BS, with 5+ years of relevant experience in a GMP manufacturing or CRO setting or MS of PhD with at least 4 years relevant experience or equivalent combination of work experience, education, and training.
  • For Principal Scientist – BS, with 10+ years of relevant experience in a GMP manufacturing or CRO setting or MS of PhD with at least 8+ years 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

 

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QC Team Lead

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

Primary Responsibilities:

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

 

Required Knowledge, Skills and Abilities  

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

 

Education and Experience Requirements

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

 

Physical Demands

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

 

Working Conditions

  • Laboratory and office environment

 

Certificates & Licenses Required

  • N/A

 

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

 

 

Senior Scientist (Mass Spectrometry and cGMP experience)

Job Responsibilities

  • Independently develops mass spectroscopy methods for small molecules and/or large molecules characterization methods (QDa, QQQ, TOF & QTOF) and works on method optimization, troubleshooting, qualification, and validation.
  • Must be able to handle complex data interpretation software and perform statistical analyses on mass spectroscopy.
  • Must have worked in cGMP environment with mass specs.
  • May independently work on analytical method development, method optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
  • Participates in scientific discussions; stays abreast of current literatures in scientific areas; independently authors analytical test methods, protocols, and reports and other documents;
  • Orders supplies for client projects and may maintain certain lab equipment.
  • Performs duties as required.

 

Skills

  • Must have experience working on mass spectroscopy techniques (QDa, QQQ, TOF & QTOF), full knowledge of and practical experience with mass spectroscopy for small molecules and/or large molecules characterization methods in cGMP environment.
  • Must be able to independently develop, optimize, troubleshoot, qualify, and validate mass spec methods.
  • Hands-on working experience with analytical method development, optimization, troubleshooting, qualification, and validation of methods such as LC (SEC, RP, IEX, HIC etc.), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods is a plus.
  • Work experience analyzing monoclonal antibodies (mAb’s), oligonucleotides, RNAs, and antibody drug conjugates (ADCs) is a huge plus.
  • Knowledge of control strategy for large molecules for drug substance and drug products, phase appropriate national and international regulatory filing strategies is preferred
  • Must be able to interpret data generated using complex data interpretation software and perform statistical analyses.
  • Training junior scientists and QC scientists on relevant assays and instruments.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to be an individual contributor and a collaborative team member
  • Ability to perform with minimal or no supervision
  • Ability to work collaboratively as part of a team
  • Ability to apply critical thinking and good problem-solving skills
  • Able to communicate scientific data effectively through presentations, protocols, test methods, and reports internally and externally
  • Maintain a culture of safety and ensure safe work practices within the lab
  • Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission
  • Communicates effectively with supervisors, colleagues, clients, and vendors

 

Education and Experience Requirements

  • Ph.D. in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas with 2 – 4 years proven industry track record and experience directly relevant to the role is required, i.e., in analytical method development and problem solving in the pharmaceutical or biotech industry
  • or M.S. in Analytical Chemistry, organic Chemistry, Biochemistry, or related areas with 4-6 years proven industry track record and experience directly relevant to the role is required, i.e., in analytical method development and problem solving in the pharmaceutical or biotech industry

 

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Senior Scientist (HPLC and cGMP experience)

Job Responsibilities

  • Independently work on analytical method development, method optimization, troubleshooting, qualification, and validation in areas related to HPLC/UPLC (SEC, RP, IEX, HIC etc.), for analysis of small molecules and/ large molecules such as mAb’s, oligonucleotides, ADCs, OACs, mRNA etc.
  • Complex data interpretation, perform statistical analyses, summarize the results and effectively present data internally and externally.
  • Maintain and trouble shoot analytical instruments in GMP environment and working with vendors on routine maintenance and qualifications of the instruments.
  • Training junior scientists and QC scientists on relevant assays and instruments.
  • Participates in scientific discussions; stays abreast of current literatures in scientific areas; independently authors analytical test methods, protocols, and reports and other documents.
  • Orders supplies for client projects and may maintain certain lab equipment.
  • Performs duties as required.

 

Skills

  • 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 is required.
  • Hands-on working experience with mass spec, capillary electrophoresis (CZE), cIEF, GC, and other analytical instruments is a plus.
  • Work experience analyzing monoclonal antibodies (mAbs), oligonucleotides, RNAs, and antibody drug conjugates (ADCs) is a huge plus.
  • Knowledge of control strategy for large molecules drug substance and drug products, phase appropriate national and international regulatory filing strategies is preferred.
  • Must be able to interpret data generated, and able present results effectively.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to be an individual contributor and a collaborative team member.
  • Ability to perform with minimal.
  • Ability to apply critical thinking and good problem-solving skills.
  • Able to communicate scientific data effectively through presentations, protocols, test methods, and reports internally and externally.
  • Maintain a culture of safety and ensure safe work practices within the lab
  • Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission.
  • Communicates effectively with supervisors, colleagues, clients, and vendors.

 

Education and Experience Requirements

  • Ph.D. in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas with 2 – 4 years proven industry track record and experience directly relevant to the role is required, i.e., in analytical method development and problem solving in the pharmaceutical or biotech industry.
  • M.S. in Analytical Chemistry, organic Chemistry, Biochemistry, or related areas with 4-6 years proven industry track record and experience directly relevant to the role is required, i.e., in analytical method development and problem solving in the pharmaceutical or biotech industry

 

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Senior Scientist, Bioanalytical Characterization

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

Primary Responsibilities:

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

 

Education Minimum Requirement:  

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

 

Required Experience and Skills:  

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

 

Preferred Experience and Skills: 

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

 

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Quality Assurance
 

Quality Assurance Specialist I-IV

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

 

Required Qualifications:

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

 

Required Skills:

  • Able to handle multiple client projects for Quality requirements.
  • Strong knowledge of Microsoft Word, Excel, and Power Point.
  • Strong written and interpersonal communication skills.
  • Ability to write and present reports/investigations and host meetings to support Quality Systems
  • Ability to train employees in a small group setting.
  • The ability to work independently and as part of a team.

 

Required Education/Experience:

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

 

Job Type: Full-time and on-site

 

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Quality Assurance Manager

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

 

Responsibilities:

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

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

 

Required Skills:

  • Able to handle multiple client projects for Quality requirements
  • Strong knowledge of Microsoft Word, Excel, and Power Point
  • Strong written and interpersonal communication skills
  • Ability to write and present reports/investigations and host meetings to support Quality Systems
  • Ability to train employees in a small group setting
  • The ability to work independently and as part of a team
  • Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required

 

Required Education/Experience:

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

 

Job Type: Full-time and on-site

 

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R&D Quality Assurance Director

NJ Bio is aggressively expanding at its new Princeton, NJ site. We are looking for an R&D Quality Assurance Director to support the establishment of a new cGMP manufacturing facility for clinical supplies (Phase 1 and 2 studies) for pharmaceutical and biotech clients in the ADC, intermediates, and small molecules space and implement the Quality Management System at NJ Bio.

 

Responsibilities:

  • Participate in the design and planning for R&D cGMP manufacturing suites.
  • Establish phase appropriate quality systems to support clinical phase manufacturing of small molecule APIs, intermediates, and antibody-drug conjugate (ADC) drug substances.
  • Ensure that all applicable Quality guidelines and regulations are followed, as appropriate for each product development phase or commercial stage.
  • Develop department organizational, resource planning, and continuous improvement strategy.
  • Manage QA professionals assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs, goal setting, and performance management in accordance with the company’s HR policies, to ensure all QA professionals are aligned and motivated towards achieving the company’s goals, values, and culture by promoting their personal and professional development while maximizing productivity.
  • Oversee all QA organization in the Site under his/her responsibility to assure that all applicable procedures, established objectives are followed and achieved.
  • Act as a senior management representative in meetings with clients, vendors, and regulatory agencies.
  • Review and approve critical quality documents
  • Review and approve of quality documents, certificates of analysis for release materials & stability samples in GMP.
  • Oversee implementation of the electronic document management system (EDMS) and administration of training in the electronic document management system.
  • Train all employees in cGMPs.
  • Execute internal audits and audits to vendors and external clients according to the established plans, needs and the criticality of the audits; provide overviews of audit findings for presentation to management as required and respond to the client audits.
  • Manage the CAPA, change control, deviation, and risk assessment programs.
  • Work closely with GMP Manufacturing, Quality Control, Facilities, and Supply Chain leadership to ensure that manufacturing, laboratory, facilities, and materials operations are conducted in compliance with current Good Manufacturing Practices (cGMP).
  • Stay abreast of regulatory and compliance requirements to ensure the company remains compliant with all applicable laws and guidelines.
  • Oversee environmental monitoring in GMP manufacturing facility.
  • Responsible for final disposition of raw materials, intermediates, API/DS batches, and DP batches
  • Create an environment where continuous improvement is part of the teams’ activities and drive for the simplification of procedures and daily tasks.
  • Create a culture of safety, quality, and compliance. Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and comply with environmental, health & safety rules/procedures, regulations and codes of practice.

 

Knowledge, Skills, and Abilities:

  • Have experience leading an R&D Quality Assurance department.
  • Experience with manufacturing, laboratory, facilities, and materials operations in compliance with current Good Manufacturing Practices (cGMP) and global regulatory authority requirements for early phase R&D APIs, ADCs, etc.
  • Must possess excellent oral and written communication skills.

 

Experience:

  • BS, MS, or PhD degree in chemistry, biology, biochemistry, microbiology, or related discipline
  • 5+ years of experience in R&D GMP manufacturing or CRO setting in QA department, preferably in ADCs, payloads, linkers, APIs, or intermediates of APIs.

 

NJ Bio offers a competitive compensation and benefits package.

 

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