Careers

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 Process R&D, Chemistry department:

Principal Scientist

Job Responsibilities

Responsibilities are for Process Development for R&D, GLP, and cGMP operations –

• Develops robust, safe, and scalable chemical processes and process engineering for operation in Kilo-lab using strong technical knowledge,
• Scale up from R&D process and manufacture on a pilot scale, pharmaceutical intermediates, Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs) and perform pilot scale purifications using Torrent systems, etc.
• Perform engineering evaluation of critical chemical process unit operations, provide assessment on practicality, efficiency, and reproducibility on scale up.
• Able to write, review, execute batch records for cGMP manufacturing
• Able to work with R&D team to support development of innovative techniques to isolate, characterize, purify materials with acumen that these will be scalable on a large scale and advise on making manufacturing process economic, comply with regulations and maintain safety
• Participates regularly in cross functional project teams within Research and Development, GMP support, and with external clients (on gram to kilo scale projects)and in group meetings and communicates results, data, verbally and written
• Handle multiple projects at a time for various clients
• Thru literature searches and search databases staying abreast of current literature in manufacturing, purification, and scale up area and advising R&D team on functional area development direction
• Suggesting innovative ways for process improvement
• Following good documentation practices and SOPS, and EHS procedures
• Training on site procedures, and maintaining safety, GLPs, and GMPs.
• Following safety protocols while handling cytotoxins, properly disposing solid and solvent waste
• Supervising scientists, includes mentoring, developing and training, monitoring their progress on projects
• Supporting lab equipment as needed and safety inspections as needed
• Providing processing equipment recommendations for purchase
• Regularly review and approve notebooks of team members and ensure team is up to date per notebook SOPs.
• Supporting Lab setup for Process team
• Estimating costs for raw materials needed for Scale up and GMP manufacturing

Skills

• Must have a thorough understanding of pilot scale manufacture in a GMP environment, GMP compliance and regulations, process implementation and operation excellence for manufacturing APIs, and intermediates; HPAPIs experience is a plus
• Must show strong technical proficiency, creativity, and independent skills to suggest experimental design and strategy for process development and scale up
• Hands-on skills and experience to plan, and execute multiple projects, think critically and be creative to resolve problems independently
• 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 systemin a GLP and GMP environment
• Technical knowledge to safely optimize synthetic organic chemistry processes for scale up of APIs, HPAPIs at pilot scale is needed
• Strong team leadership ability
• Good interpersonal skills to be an effective member of a multi-disciplinary team of chemists, bioconjugation, analytical and quality assurance specialists
• Ability to be an individual contributor and a collaborative team member
• Excellent scientific verbal and written communication skills
• 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.

Education and Experience Requirements

Ph.D. in Chemistry with over 5 years industry experience or M.S. in Chemistry with 10 plus years in industry. cGMP experience is preferred for APIs.

 

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Associate Scientist

Job Responsibilities

• Support Senior and Principal Scientist –
  • In hands-on scalable processes in kilo-lab for manufacturing pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs) after training with supervision
  • For safely optimizing synthetic organic chemistry processes for scale up into large glassware, pilot plant tech transfers projects for APIs, and HPAPIs under supervision
  • Running samples for characterization on NMR, MS, HPLC
  • In pilot scale purifications using Teledyne ISCO purification and Torrent system
  • Carry out literature searches and mine information for ongoing work from search
  • Maintain equipment, chemical inventory, and provide lab support
  • Execute daily and weekly tasks assigned
• Perform safe lab practices; comply with Site safety protocols and Site Standard Operating Procedures (SOPs)
• Maintain a detailed lab notebook
• Perform other duties as required

Skills

• Ability to work collaboratively as part of a team.
• Ability to communicate effectively, orally, in writing and to listen actively.
• Ability to demonstrate a willingness to learn.

Education and Experience Requirements

• S. in Chemistry with 0-5 years’ industry experience for Associate Scientist
• cGMP experience is a plus

 

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Senior Associate Scientist

Job Responsibilities

• Under limited supervision –
  • Perform hands-on safe, and scalable processes for operation in Kilo-lab
  • Work on kilo-lab equipment to prepare pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs) after training
  • Work with Senior/Principal Scientist with hands-on safe, and scalable processes for operation in Kilo-lab
  • On kilo-lab equipment to prepare pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs) after training
  • For safely optimizing synthetic organic chemistry processes for scale up into large glassware, pilot plant tech transfers projects for APIs, and HPAPIs
  • Running samples for characterization on NMR, MS, HPLC and analyze data
  • In pilot scale purifications using Teledyne ISCO purification and Torrent system
  • Carry out literature searches and mine information for ongoing work from search
  • Maintain equipment, chemical inventory, and provide lab support;
  • Execute daily and weekly tasks assigned;
• Perform safe lab practices; comply with Site safety protocols and Site Standard Operating Procedures (SOPs)
• Maintain a detailed lab notebook
• Perform other duties as required

Skills

• Ability to perform with limited supervision.
• Ability to work collaboratively as part of a team.
• Ability to communicate effectively, orally, in writing and to listen actively.
• Ability to apply critical thinking and good problem-solving skills.
• Ability to demonstrate a willingness to learn.

Education and Experience Requirements

• B.S. in Chemistry with 0-5 years industry experience or B.S. in Chemistry with over 5 years industry experience.
• cGMP experience is a plus

 

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cGMP Manufacturing Engineer, Chemical Process Development & Bioconjugation

The Role
cGMP Manufacturing Engineer will be involved in executing cGMP manufacturing operations (clinical batches) and involved in process development. The engineer will also support GMP facility and equipment qualifications, cleaning/sanitization procedures and support functions of equipment, facilities and instruments.

Job Responsibilities

• Weighing and Manufacturing of GMP, R&D and Clinical Batches
• Equipment Staging, Setup, Operation, Disassembly and Cleaning with no supervision
• Performance Verification/Calibration of Instruments
• Material Handling
• Facility Sanitization & Equipment Cleaning Procedures
• Training and Mentoring New and Current GMP Associates
• Execution of GMP, R&D and Clinical batch records with minimal or no supervision
• Authors and reviews GMP equipment Standard Operating Procedures (SOPs)
• Author and review Batch Records
• Tech transfer of processes from R&D to scale up and GMP manufacturing
• Lead commissioning of facilities and processing equipment
• Hands on implementation of manufacturing process improvement using scientific principles and robust engineering.

Additional responsibilities include:

• Execution of manufacturing batch records and material sampling
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA.
• Complies with all company and site policies and procedures.
• Making suggestions for continuous improvement
• Providing overtime as needed
• Is available for other duties as required

Education and Experience:

• B.S./M.S. Chemical Engineering/Chemistry with 2-5 years’ experience of cGMP manufacturing in life science industry setting.
• High potency API manufacturing experience is a plus.

Other Skills, Abilities, Qualifications:

• Organizational skills
• Ability to work with others in a team environment.
• Ability to work with minimal supervision
• Attention to detail

Physical Demands:

• The employee must occasionally lift and/or move up to 30 pounds.
• Must be able to qualify for respiratory protective equipment use.

 

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Scientist

NJ Bio is a growing CRO that provides integrated chemistry and biology services to the biotech and pharma sectors. Main services include multistep organic synthesis, medicinal chemistry, bioconjugation, and flow chemistry. The company is headquartered in Princeton, NJ, with an additional chemistry facility in Bristol, PA.

The selected candidate will work at the Princeton site on the preparation of bioconjugates (e.g., antibody-drug conjugates, protein-drug conjugates, protein-peptide conjugates, peptide-drug conjugates, protein-oligonucleotide conjugates, protein-fluorophore conjugates, protein-chelator conjugates). The Scientist position will work under the tutelage of an experienced Senior Scientist or Principal Scientist of Bioconjugation Chemistry. This role requires excellent communication skills and the ability to work in a dynamic and collaborative environment. This position also offers significant growth opportunities within our growing organization. No previous experience in bioconjugation required.

Desired Qualifications

• Degree in Protein Engineering, Cell Biology, Biochemistry, Biology, Molecular Biology, or related discipline, plus 0-1 year of related experience in a pharmaceutical industry setting.
• Experience with preparation and purification of proteins, antibodies, oligos, and or bioconjugates (< 100 mg) using modern protein purification methodologies such as HPLC, ultrafiltration /diafiltration (UF/DF) and tangential flow filtration (TFF), hydrophobic interaction chromatography (HIC), ion-exchange, affinity chromatography, and/or size-exclusion chromatography (SEC) is required.
• Strong background in antibody/protein engineering and or molecular biology.
• Experience in cell-based assays would be an important asset.
• Experience in monoclonal antibody design & development and biophysical characterization (i.e., FPLC, HPLC, UPLC and mass spectrometry) is needed.
• Working knowledge in mammalian cell culture including 3D cell culture is needed.
• Experience in plasmid design, in vitro transcription or DNA/RNA synthesis is a plus.
• Excellent written and verbal communication skills that allows to work in a highly interactive team environment.
• Works creatively, proactively, and collaboratively with other departments to support complex scientific projects.
• Under supervision, must have the ability to manage several projects simultaneously.
• Adherence to organizational EHS policies and maintenance of clean, safe workplace per established procedures is a must.
• Willingness to use technological advancements to improve processes.

Education and Other Skills:

• BS, MS or PhD in Degree in Protein Engineering, Cell Biology, Biochemistry, Biology, Molecular Biology or related discipline with 0-1 year of pharmaceutical/biotech experience in related field.
• Needs exposure to the bioanalytical characterization and development of proteins is needed.
• Possess critical thinking and problem-solving skills.
• Knowledge or understanding of bioconjugation (mg- to multi-gram preparation) and exposure to the bioanalytical characterization and development of proteins and bioconjugate therapeutics for protein engineering is a plus.

NJ Bio offers a competitive compensation and benefits package.

 

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Senior Scientist

NJ Bio is a growing CRO that provides integrated chemistry and biology services to the biotech and pharma sectors. Main services include multistep organic synthesis, medicinal chemistry, bioconjugation, and flow chemistry. The company is headquartered in Princeton, NJ, with an additional chemistry facility in Bristol, PA.

The selected candidate will work at the Princeton site on the preparation of bioconjugates (e.g., antibody-drug conjugates, protein-drug conjugates, protein-peptide conjugates, peptide-drug conjugates, protein-oligonucleotide conjugates, protein-fluorophore conjugates, protein-chelator conjugates). The Senior Scientist position will work under the tutelage of an experienced Principal Scientist or Director of Bioconjugation Chemistry. This role requires excellent communication skills and the ability to work in a dynamic and collaborative environment. This position also offers significant growth opportunities within our growing organization. No previous experience in bioconjugation required.

Desired Qualifications

• Degree in Protein Engineering, Cell Biology, Biochemistry, Biology, Molecular Biology or related discipline, with 2-5 years of related experience in a pharmaceutical or biotechnology industry setting.
• Must be knowledgeable and have hands on experience in Preparation and purification of proteins, antibodies, oligos, and or bioconjugates (< 100 mg) using modern protein purification methodologies such as HPLC, ultrafiltration/diafiltration (UF/DF) and tangential flow filtration (TFF), hydrophobic interaction chromatography (HIC), ion-exchange, affinity chromatography, and/or size-exclusion chromatography (SEC).
• Strong background in antibody/protein engineering and or molecular biology is required.
• Needs to have cell-based assays experience.
• Experience in monoclonal antibody design & development and biophysical characterization (i.e., FPLC, HPLC, UPLC and mass spectrometry) is needed.
• Must have experience in mammalian cell culture including 3D cell culture.
• Experience in plasmid design, in vitro transcription or DNA/RNA synthesis is a plus.
• Excellent written and verbal communication skills that allows to work in a highly interactive team environment.
• Works creatively, proactively, and collaboratively with other departments to support complex scientific projects.
• Must have the ability to manage several projects simultaneously under minimum supervision.
• Adherence to organizational EHS policies and maintenance of clean, safe workplace per established procedures is required.
• Willingness to use technological advancements to improve processes.

Education and Other Skills:

• Degree in Protein Engineering, Cell Biology, Biochemistry, Biology, Molecular Biology or related discipline with 2-5 years of relevant pharma or biotech industry experience.
• In depth exposure to the bioanalytical characterization and development of proteins is needed.
• Management/supervisory experience is a plus.
• Demonstrable experience in developing scalable processes for the preparation of conjugates preferred (i.e., tech transfer, cGMP).
• Possess critical thinking and problem-solving skills.
• Knowledge or understanding of bioconjugation (mg- to multi-gram preparation) and exposure to the bioanalytical characterization and development of proteins and bioconjugate therapeutics for protein engineering is a plus.

NJ Bio offers a competitive compensation and benefits package.

 

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Senior/Principal Scientist in Mass Spectroscopy

NJ Bio, Inc. analytical department is seeking a highly motivated bioanalytical Senior/Principal Scientist to join our bioanalytical group. In this role you will support development of LC-MS based technologies to characterize antibodies, ADCs, oligonucleotides for quantitative and qualitative analysis in various biological matrices. Development of methods to measure the stability and biotransformation of bioconjugates from in vitro and in vivo will be an important part of the role. You will have opportunities to utilize state-of-art LC-MS (QQQ, TOF, Q-TOF) coupled with various sample preparation platforms to solve critical analytical problems, and work with different groups.

Job Responsibilities

• Proven experience in mass spectrometry and chromatographic techniques for the analysis of any of the following: proteins, peptides, antibodies, antibody-drug conjugates (ADCs), oligonucleotides and oligonucleotide-antibody conjugates (OACs).
• Apply mass spectrometry analytical techniques to characterization/quantitation of various types of analytes particularly mAb, ADC’s, free payloads & metabolites in various sample matrices.
• Collaborate across different departments e.g., bioconjugation, bioanalytical and chemistry, to advance antibody drug conjugate (ADC), siRNA, oligonucleotides, and other therapeutics programs to support clients.
• Lead bioanalytical team to develop LC-MS, LC-MS/MS methods to quantify free payload in biological matrices to support PK and PD analysis.
• Provide mass spectrometry support to scientists in bioconjugation teams platform and other groups.
• Demonstrated ability to build and maintain positive and collaborative relationships with peers, team members, and external business partners such as clients.
• Review of validation reports, sample analysis reports, SOWs, protocols, and reports
• Hands on experience on MS data analysis software and data interpretation.
• Experience managing and training junior staff and individual contributors.
• Ability to work on multi-task and work in a team environment.
• Oversee the method development and technical transfer at external vendors.
• Working independently and prioritizing work to meet deadlines with direction from supervisor.
• Participating in the instruction and training of others on Mass spec instruments.
• Perform related duties as required.

Skills

• Develop LC-MS / MS based bioanalytical for quantification / characterization of different biomolecules in various biological matrices.
• Develop and execute a bioanalytical strategy as a bioanalytical project lead.
• Develop timelines and plan / request adequate resources to support critical program activities and meet key deliverables.
• Prepare method SOPs, validation, and sample analysis plans. Analyze data, summarize results, and prepare reports.
• In-depth scientific knowledge about drug metabolism, enzymology, bioactivation, and ADME.
• Demonstrates leadership capabilities especially in a team environment.

Education and Experience Requirements

• A Ph.D. in analytical chemistry, chemistry, pharmaceutical sciences, biotechnology, or related field, with 3+ years pharmaceutical or biotechnology industry experience or a master’s degree in the above fields with 6+ years industry experience.
• Prior experience with ADCs, OACs research is a major advantage.

Work Environment

• Lab and office, on-site full-time

 

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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 the Bioconjugation Team:

 

Associate Scientist

Job Responsibilities

Under department supervision, plan, setup, monitor and purify bioconjugation reaction using aseptic techniques; characterize and identify bioconjugates using LC-MS, HPLC and/or Capillary Electrophoresis; maintain a detailed lab notebook; maintain equipment, and provide lab support; provide data in a detailed report; Plan and execute daily and weekly schedule; perform safe lab practices; comply with Site safety protocols and Site Standard Operating Procedures (SOPs). Perform additional duties as required.

Skills

• Ability to work collaboratively as part of a team.
• Ability to communicate effectively, orally, in writing and to listen actively.
• Ability to apply critical thinking and good problem-solving skills.
• Demonstrate a willingness to learn.

Education and Experience

B.S. in Biochemistry, Protein Chemistry, or other related fields with 0-3 years’ industry experience.

 

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Senior Associate Scientist

Job Responsibilities

Under department supervision, plan, setup, monitor and purify bioconjugation reaction using aseptic techniques; characterize and identify bioconjugates using LC-MS, HPLC and/or Capillary Electrophoresis; maintain a detailed lab notebook; maintain equipment, and provide lab support; provide data in a detailed report; Plan and execute daily and weekly schedule; perform safe lab practices; comply with Site safety protocols and Site Standard Operating Procedures (SOPs). Perform additional duties as required.

Skills

• Ability to work collaboratively as part of a team.
• Ability to communicate effectively, orally, in writing and to listen actively.
• Ability to apply critical thinking and good problem-solving skills.
• Demonstrate a willingness to learn.

Education and Experience

B.S. in Biochemistry, Protein Chemistry, or other related fields with >3 years’ industry experience.

 

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Principal Scientist

Job Responsibilities

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

 

Skills

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

 

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

 

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Principal Scientist- Oligonucelotide Chemistry

NJBIO is seeking a highly motivated synthetic chemist with experience in phosphoroamidite synthesis and oligonucleotides synthesis to fill a newly created position. The successful candidate will have a strong background in modified nucleotides and experience in modified oligonucleotides. Experience in downstream purification of the oligonucleotides and their characterization by LCMS. The successful candidate will prepare synthetic DNA/ RNA and chemically modified synthetic DNA/ RNA oligonucleotides using solid phase synthesis and perform downstream purification and characterization.

Summary of Key Responsibilities

• Design and execute the automated synthesis, purification, and analysis of oligonucleotides with various chemistries and scales
• Design and synthesize various chemical modifications to improve oligonucleotide properties
• Design and execute various bioconjugaton strategies and techniques to prepare oligonucleotide conjugates.
• Improve and/or develop new processes of synthesis and purification to expand upon current capabilities
• Troubleshoot and perform routine maintenance on critical instrumentation such as automated synthesis platforms, HPLC, etc.
• Analyze, organize, and present data at internal and external meetings

 

Qualifications

• PhD in Chemistry, Biochemistry, or related discipline with 5+ years’ experience in a pharmaceutical industrial working in oligonucleotide or oligo-conjugation space or MS (8+ years)/BS (10+ years) in a relevant field
• Strong experience in solid-phase synthesis techniques (RNA/DNA/peptide synthesis is required) and bioconjugation synthesis techniques is preferred

 

Skills

• Synthetic knowledge and purification of monomers is an important asset
• Strong laboratory skills and experience with analytical instrumentation such as HPLC, LC-MS, etc. with the ability to analyze, interpret, and clearly present data
• The ability to apply his/her knowledge to a new area of study as well as to thrive in a highly interdisciplinary team environment and show leadership ability
• High degree of flexibility to work with a small team in a fast-paced environment
• Leadership experience is an important consideration

 

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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 Quality Assurance:

 

Metrologist (I, II, III, IV, V, Senior, Manager)

NJ Bio is currently seeking to hire a Metrologist with cGMP manufacturing background in pharmaceuticals or biotechnology. This role will report into Quality Assurance Manager.

Job Responsibilities:

• Work with end users, management, QA, and vendors to acquire, install, and qualify new equipment.
• Schedule preventative and non-routine maintenance of laboratory and process equipment. Work closely with end users and management to minimize conflicts and downtime.
• Maintain work orders for instrument repairs and manage assets and their life cycles.
• Set and maintain resolution and calibration of all GMP and R&D/Facility equipment such as mass specs, etc.
• Get quotes for repairs, calibrations, qualifications, and PMs including parts and labor.
• Manage work outsourced to third-party analytical and metrology service providers.
• Review service provider calibration and qualification procedures to ensure that they follow USP, EU, or other cGMP and industry standards.
• Be the point person for all outside vendor activities and troubleshooting activity and coordinate repairs.
• Escort outside service providers and ensure that they comply with all safety and GMP policies.
• Execute all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Prepare and execute standard operating procedures (SOPs), URS, qualification protocols (IQ, OQ, PQ), reports, etc.
• Conduct OOT, 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.
• Manage, organize, and maintain all logs, certificates, records, and documents according to organizational GDP policies.

 

Skills:

• Ability to work independently and in a team setting.
• Hands-on experience with various analytical and process equipment and instrumentation.
• Excellent written and verbal communication skills.
• Excellent problem solving and troubleshooting skills.
• Performs work with high level accuracy and attention to detail, and is good with prioritization, time management, and organization.
• High proficiency with MS Office Suite (Outlook, Word, Excel, PowerPoint) and SharePoint.
• Possesses excellent skills to communicate.
• Strong critical thinking, problem solving skills is detail-oriented, and has ability to coordinate multiple projects simultaneously, works well under pressure to meet deadlines.
• Highly self-motivated to join a fast-paced company and has willingness to learn on the job.

Education and Experience:

• BS degree in engineering, chemistry, biology, biochemistry, or related discipline
• 2-10 years of experience in a GMP manufacturing at a CRO is required, with minimum of 2 years in metrology.
• Familiar with FDA and OSHA regulations is a must.
• Experience with calibration and maintenance systems is a plus.

Job Type:

• Full-time, on-site

 

NJ Bio offers a competitive compensation and benefits package including 401(k), health, vision, dental, and life insurance plans.

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Scientific Proposal Manager, Synthetic Chemistry, Bioconjugation, and GMP Manufacturing

NJ Bio, Inc. is a rapidly growing quality contract research organization that provides chemistry and biopharmaceutical services specializing in bioconjugation, custom synthesis, bioassays, and process development.

NJ Bio is currently seeking to hire a Scientific Proposal Manager with a synthetic chemistry, bioconjugation, and cGMP manufacturing background in pharmaceuticals or biotechnology to prepare high-quality proposals for business opportunities in a timely manner. This position requires excellent technical content writing and proof-reading skills, coordination, and communication skills to collaborate with subject matter experts (SMEs) for technical input and with clients during the initial proposal development phase as well as with project management to ensure seamless project introduction at kick-off meetings. Due to the nature of the role, the Proposal Manager will need to have the capacity to work flexibly outside of normal business hours during the active proposal phase if required. The role offers significant growth opportunities within the organization.

Primary Responsibilities

• Respond to client requests in a timely, knowledgeable, professional, and courteous manner with high-quality proposals and quotes, including Requests for Information (RFI) and Request for Quote (RFQ) responses, capabilities statements, etc. for chemistry, bioconjugation, and GMP manufacture of phase I and IIA clinical supplies
• Collaborate extensively with business development team members and clients to clearly define scope, timelines, resource requirements, strategy, deliverables, and risk mitigation.
• Assemble technical information such as synthesis routes using search databases and support from technical SMEs, pricing information, and scope changes in proposal generation process.

Secondary Responsibilities

• Assist project management to ensure scope changes are captured, timelines are being adhered to, and participate in kick-off meetings.
• Support business development and marketing initiatives to grow the client base, suggest improvements to proposal process, cost models and overall process of RFQ responses.
• Occasional business travel to tradeshows, conferences, or client meetings (≤ 5%).

Qualifications

• BS, MS or PhD in organic chemistry, biochemistry, or related discipline. PhD with 2-3 years of pharmaceutical or biotechnology industry experience, MS or BS with 3-5 years of industry experience will be considered.
• Prior work experience in industry is required, CRO/CDMO experience is desirable.
• At least 1-2 years’ experience in cGMP manufacturing of small molecules, ADCs, or APIs is required.
• Able to independently create and develop highly technical proposal sections, including information research and synthesis from multiple sources into a cohesive, easy-to-read, and persuasive final product.
• Liaise with subject matter experts to gather data to support the proposal writing process.
• Performs work with high level accuracy and attention to detail, excellent writer, and is good with prioritization, time management, and organization.
• High proficiency with MS Office Suite (Outlook, Word, Excel, PowerPoint), Adobe Acrobat, ChemDraw, Reaxys, and SharePoint.
• Possesses excellent skills to communicate with peers, management, and clients in chemistry, biotechnology, and ADC field.
• Strong critical thinking, problem solving skills is detail-oriented, and has ability to coordinate multiple projects simultaneously, works well under pressure to meet deadlines.

NJ Bio offers a competitive compensation and benefits package including 401(k), health, vision, dental, and life insurance plans.

Job Type: Full-time

 

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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 Human Resources team and is looking for dedicated and talented individuals.

Human Resources Manager (with Life Sciences experience)

Job Responsibilities

• Responsible for ensuring compliant, efficient, and timely recruitment and staffing efforts for hiring units using the applicant management tool for all staff positions within assigned schools/units. This includes the posting of new and vacant positions, reviewing print/online advertisement, managing applicant pools from screening, and referring candidates to hiring manager, coordinating the selection, employment offers, hiring and onboarding of final candidates, background investigations, and participating in job fairs.
• Facilitate the employee onboarding process to ensure the employee has a positive experience and has all the training and equipment to operate effectively within the company and role
• Create and regularly update all job descriptions.
• Responsible for administering Benefits Program including group health, dental, vision. 401k, Life Insurance. Provide interpretation of benefits and policies to employees.
• Manage leave of absence and workers compensation programs.
• Process payroll semi-monthly.
• Maintains knowledge of legal requirements and government reporting regulations affecting human resources functions and ensures policies, procedures, and reporting are incompliance.
• Maintain company policies and procedures to ensure equitable practices and legal compliance for the organization. Recommend adjustments to practices as appropriate as laws change.
• Assist in assembling reports as requested, such as EEO reporting, HR Year-end reports, reporting for regulatory compliance.
• Assist with the performance evaluation process.
• Perform other duties as required.

Skills

• Excellent use of technology including Microsoft Suite, Zoom.
• Ability to work under multiple deadlines and manage simultaneous projects.
• Strong problem-solving abilities, time and task management, and organizational skills.
• Ability to communicate effectively, orally, in writing and to listen actively.

Education and Experience

Bachelor’s degree in human resources or a related field required and 5-7 years of human resources experience or an equivalent combination of both education and experience which meets the required knowledge, skills, and abilities. Experience in a life sciences setting is preferred. Professional in Human Resources (PHR) and or SPHR certification preferred.

 

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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 expanding its Global Operations team and is looking for dedicated and talented individuals.

Executive Administrative Assistant

Job Responsibilities

1. Creates & maintains effective workflow and communications to accomplish the work of the executive management team including handling of a variety of projects and tasks simultaneously.
2. Manage senior leadership calendars, review, and respond to emails, and schedule simple (e.g., 1 on 1s) to more complex meetings (i.e., monitoring client/prospect meeting requests, etc.) either as on site or virtual meetings.
3. Develop & maintain strong, credible relationships across company executives, supported teams and clients, anticipate, and respond quickly to changes and encourage others to do the same.
4. Screen incoming emails & route correctly to proper executive for action, direction, or follow-up.
5. Schedules, plans, coordinates executive staff meetings including making presentations, reviewing drafts for language, grammar, formats, planning & sharing agendas, booking rooms, special events, developing or collating presentation materials, reviewing minutes, next steps, assigning action items and follow ups.
6. Maintain confidential information, records, files, and maintains highest level of confidentiality.
7. Manage domestic & international travel schedules for executives & support expense reporting.
8. Completes special projects as assigned.

Skills

• Must be high-performing & experienced professional with high level of integrity & confidence.
• Must be highly organized, possess exceptional administrative, verbal, & written communication skills.
• Ability to prioritize, plan, and multitask, track activities of department, senior leaders, and must be excellent at setup of multiple meetings with internal members and clients independently.
• Seek challenges, anticipate needs, and be self-motivated.
• Expert knowledge of Microsoft Office, especially PowerPoint, Outlook, SharePoint, Teams, Zoom, and internet search engines and able to learn systems and procedures quickly.
• Ability to carry out all functions in accordance with pre-established procedures and team up with colleagues to meet deadlines established for the Department.
• Ability to discreetly handle sensitive and confidential material.
• Strong organizational savvy.
• Must effectively manage conflicting priorities, be adaptable, and comfortable in a fast-paced environment.
• Proven track record of assisting industry executives.
• Good understanding of domestic and international travel management.
• At least 10 years of administrative support experience is required.
• This is an On-site role

Education and Experience

Bachelor of Science, Business Administration and Management or equivalent bachelor’s degree and at least 10 years administrative or comparable experience or an equivalent combination of both education and experience which meets the required knowledge, skills, and abilities.

Prior Executive Assistant experience preferred.

 

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Validation Engineer, Biopharma/Pharma Operations (III, IV, Senior, Principal, Manager)

NJ Bio is aggressively expanding at its new Princeton, NJ site. We are looking for a Validation Engineer (title depending on experience) to support cGMP clinical manufacturing operations.

THE ROLE – 

The Validation Engineer is responsible for validation activities in support of cGMP biopharmaceutical/pharmaceutical manufacturing. The Validation Engineer conducts validation/qualification activities for projects within timelines and monitors, analyzes and assists to improve pharmaceutical processes or systems. Complies with requirements of the company Environmental Health and Safety requirements, OSHA requirements and cGMP compliance for US, EU, Japan, and Korea. This role is responsible for writing user requirements, writing, executing, protocols and reports for process equipment, lab, process instruments (installation, operation, and performance qualifications) and for validations for process and cleaning. This role will report into Site Operations and EHS Head.

Job Responsibilities

• Authors, reviews, and executes commissioning reports for facilities and environmental monitoring/control systems or facility for clinical manufacturing.
• Prepare, execute, and review System Impact Assessments (SIA), Requirements Specifications (RS), Design Specifications (DS), Functional Requirements Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Validation Plans (VP), and Validation Summary Report (VSR) for equipment and critical systems and utilities, Process Performance Qualification (PPQ) for the API manufacturing process.
• Periodically reviews commissioning, qualification, and validation related system lifecycle documentation such as user requirements, commissioning, and qualification protocols.
• Develop and execute protocols for PPQs, cleaning validation, and facilities validation.
• As SME for all GXP engineering activities, performs risk assessment and writes mitigation plans and executes mitigation steps to ensure maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities including evaluation of changes to validated systems, processes, procedures, in terms of their effect on state of validation using change controls in complying with Quality systems.
• Works independently to execute validation protocol activities while communicating to management on regular basis and works cross-functionally with Manufacturing, Facilities, Operations, Quality Assurance, and Project Management to achieve all project deliverables, and build strong working relationships.
• Conducts computer validation strategies including URS, validation plans, function and design specs, test protocols, risk assessments, and validation reports to meet FDA 21CFR part 11 compliance.
• Reviews and ensure document changes for process, materials, procedures, follow regulatory requirements, ISO, and company quality systems.
• Review validation and deviation impact and recommend corrective actions to appropriate departments and work to implement the required changes needed for corrective action.
• Conduct OOT, risk assessment, and root cause investigations and/or assist management with these investigations and write deviations, change controls, and CAPAs, and/or assist management with these documents based on sound engineering principles.
• Conducts sanitization reviews to keep facility cGMP compliant.
• Author SOPs and Work Instructions as needed to comply with regulations.
• Supports and reviews design, construction, start-up, validation, commissioning, and operation of facilities and processes in cGMP suites for clinical manufacture of High-potent APIs, general APIs, and intermediates.
• Responsible for compliance of capital projects, critical utilities, environmental monitoring, equipment qualification, maintenance, and calibration programs.
• Perform other duties as needed.

Skills

• Has strong advanced technical writing, verbal communication, and presentation skills.
• Proficient in Microsoft Office
• Has excellent organization skills and is very detail oriented.
• Can juggle multiple projects.
• Is a collaborative team player with good interpersonal skills.
• Able to do ISO cleanroom gowning and PPE, as required by site procedures.
• Is passionate about continuous improvement.
• Must be able to work cross-functionally with Facilities, Site Operations, EHS, Manufacturing, Quality Control, and Quality Assurance as well as independently.
• Worked with Solidworks Software, Autodesk Inventor, HVAC Engineering Experience, HVAC Design Experience, Piping Design, Coil Design, electrical mechanical, etc. and can understand and verify piping & instrument diagram, engineering layout, drawing and documents.
• Knowledge of Good Documentation Practices, Pharma GxPs, cGMPs, Engineering Qualification Procedures, tools for Risk Assessment, FMEA, others are a must.

Education and Experience

• Bachelor’s degree in engineering or pharmaceutical manufacturing, chemistry, biotechnology, or related scientific discipline required with a minimum of four (4) plus years of pharmaceutical industry experience or combination of direct work experience in Validation, QA, Manufacturing, or Engineering in cGMP environment.
• Combination of equipment qualification, process validation, or cleaning validation is acceptable.
• Must have knowledge and experience in multiple regulatory inspections and current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes.
• Possess good fundamentals of commissioning, qualification validation, practices, including applicable regulations.
• Stays abreast of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMEA) for validation of GMP facilities.

 

Job Type: Full-time, on site

NJ Bio offers a competitive compensation and benefits package including 401(k), health, vision, dental, and life insurance plans.

 

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