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Antibody Drug Conjugates Services

Careers

NJ Bio, Inc. is a rapidly growing quality contract research organization 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:

Chemistry

Associate Scientist

Job Responsibilities

Under department supervision, plan, setup, monitor and workup chemical reactions and isolate product; optimize reaction conditions for improved yields and outputs; purify compounds by different methods; characterize and identify compounds using MS and NMR; maintain a detailed lab notebook; carry out literature searches and mine information for ongoing work from search engines; maintain equipment, chemical inventory, and provide lab support; run multiple reactions daily and 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 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.
  • Ability to demonstrate a willingness to learn.

Education and Experience Requirements

B.S. in Chemistry with 0-5 years’ industry experience.

Email To Apply – jobs@njbio.com


Senior Associate Scientist

Job Responsibilities

Under minimal supervision, plan, setup, monitor and workup chemical reactions and isolate product; purify compounds by different methods; characterize and identify compounds using MS and NMR; maintain a detailed lab notebook; carry out literature searches and mine information for ongoing work from search engines; independently prepare presentations for own work and present results; maintain equipment, chemical inventory, and provide lab support; run multiple reactions daily; prepare client reports; participate in project meetings; perform safe lab practices; Perform duties as required.

Skills

  • 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.
  • Ability to apply critical thinking and good problem-solving skills.
  • Ability to demonstrate a willingness to learn.

Education and Experience Requirements

M.S. in Chemistry with 0-3 years industry experience or B.S. in Chemistry with minimum 5 years industry experience.

Email To Apply – jobs@njbio.com


Scientist

Job Responsibilities

Under minimal supervision, plan and execute chemical syntheses from milligram to hundreds of grams scales; plan and execute short-term, mid-term and long-term goals; contribute to scientific discussions; stay abreast of current literatures in scientific areas; design synthetic routes for projects; prepare project reports for clients; maintain equipment, chemical inventory and provide lab support; Perform duties as required.

Skills

  • Extensive knowledge with analytical techniques like mass spectrometry and Nuclear Magnetic Resonance.
  • Ability to design synthetic routes for projects.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to 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.
  • Ability to apply critical thinking and good problem-solving skills.
  • Ability to demonstrate a willingness to learn.

Education and Experience Requirements

Ph.D. in Chemistry with 0- 2 years industry experience or M.S. in Chemistry with 3-5 years industry experience.

Email To Apply – jobs@njbio.com


Senior Scientist

Job Responsibilities

Plan and execute chemical syntheses from milligram to hundreds of grams scales; conduct purification and characterization of compounds; plan the work for a team of scientists; carry out literature searches using search engines; maintain a detailed lab notebook; check team’s progress regularly; communicate with clients on progress and project status; stay abreast of current literature in scientific areas; write project reports containing procedures and experimental details for clients; maintain time sheets, equipment, chemical and project inventory and provide lab support; Perform duties as required.

Skills

  • Extensive knowledge with analytical techniques like mass spectrometry and Nuclear Magnetic Resonance.
  • Ability to work on purification and characterization of compounds.
  • Ability to effectively plan the work of others.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to supervise 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 Requirements

Ph.D. in Chem with 2-5 years industry experience or Post-Doc in Chemistry with 0-2 years of industry experience or M.S. in Chemistry with 5-10 years of industry experience.

Email To Apply – jobs@njbio.com


Principal Scientist

Job Responsibilities

Independently plan project responsibilities; plan work for each project and execute it towards a timeline while maintaining productivity; plan and execute multiple chemical syntheses from milligram to hundreds of grams scales and conduct purification and characterization of compounds; liaise with purchasing to follow up on arrivals and help procurement with selection of materials; prepare and present project status and progress updates to clients; provide input on equipment purchases; get regular updates from project group; contribute to scientific discussions; check and maintain up to date lab notebooks for team on projects; supervise Scientists, Associate and Sr. Associate Scientists; maintain performance management metrics for personnel if supervising personnel; stay abreast of current literature in scientific areas; write project reports containing procedures and experimental details for clients; maintain equipment, chemical inventory and lab support; Perform duties as required.

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 supervise 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 Requirements

Ph.D. in Chemistry with over 5 years industry experience or Post Doc in Chemistry with over 3 years industry experience or M.S. in Chemistry with 10 plus years in industry.

Email To Apply – jobs@njbio.com

Molecular Biology/ Protein Engineering/Cell Biology

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.

Email To Apply – jobs@njbio.com


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.

Email To Apply – jobs@njbio.com


Principal 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). 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. Some experience in bioconjugation is a plus.

Desired Qualifications

  • Degree in Protein Engineering, Cell Biology, Biochemistry, Biology, Molecular Biology or related discipline with 5+ years of relevant pharma or biotech industry experience.
  • 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 is needed.
  • 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.
  • 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.
  • Adherence to organizational EHS policies and maintenance of clean, safe workplace per established procedures.
  • Be able 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 5+ years of relevant pharma or biotech industry experience.
  • In depth experience working with bioanalytical characterization and development of proteins is needed.
  • Management/supervisory experience is essential.
  • 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.

Email To Apply – jobs@njbio.com

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:

Scientist

Job Responsibilities

Under supervision, works on analytical method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following:  LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods. Participates in scientific discussions; stays abreast of current literatures in scientific areas; Supports senior analytical staff in authoring analytical test methods, protocols, and reports and other document; maintains lab equipment, orders supply for lab, and provides general lab support. Performs duties as required.

Skills

  • Must have full knowledge of and practical experience with analytical instruments and method development using instruments such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods
  • Must be able to handle complex data interpretation software and perform statistical analyses
  • Be able to work on multiple projects simultaneously upon being trained on analytical areas under supervision
  • Ability to be an individual contributor and collaborative team member
  • Ability to apply critical thinking and good problem-solving skills
  • Demonstrates a willingness to learn and work pro-actively.
  • Able to communicate scientific data effectively through presentations, protocols, test methods, and reports internally and externally.
  • Maintain a culture of safety and ensure safe work practices within the lab
  • Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission.
  • Communicates effectively with supervisors and colleagues

Education and Experience Requirements

Ph.D. in Analytical Chemistry, organic Chemistry, Biochemistry or related areas with 0- 2 years industry experience or M.S. in Analytical Chemistry, Organic Chemistry, Biochemistry, or related areas with 2-4 years industry experience or more than 6 years of relevant experience with bachelor’s degree.

Email To Apply – jobs@njbio.com


Senior  Scientist

Job Responsibilities

Independently works on analytical method development, method optimization, troubleshooting, qualification, and validation in areas related to some or all of the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (QDa, QQQ, TOF, & QTOF), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods. 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 hands-on working experience with analytical method development, optimization, troubleshooting, qualification, and validation of methods such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (QDa, QQQ, TOF & QTOF), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods
  • Work experience analyzing monoclonal antibodies (mAbs), 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
  • 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 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 3-5 years proven 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.

Email To Apply – jobs@njbio.com


Principal Scientist

Job Responsibilities

Independently works on analytical method development, method optimization, troubleshooting, qualification, and validation in areas related to LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (QDa, QQQ, TOF, & QTOF), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods. Key aspect is taking a leadership role in proposing and implementing new platform technologies that increase analytical capabilities, improve process efficiencies, and mentor train and develop junior colleagues. Independently plans project responsibilities, executes activities against timelines, leads project scientific discussions; stays abreast of current literature in scientific areas; independently authors and reviews analytical test methods, protocols, and reports and other documents; liaises with purchasing to follow up on arrivals and help procurement with selection of materials; prepare and present project status and progress updates to clients; provide input on equipment purchases; get regular updates from project group; contribute to scientific discussions; check and maintain up to date lab notebooks for team on projects; supervises scientists; Performs duties as required.

Skills

  • Must have hands-on working experience and deep knowledge in analytical method development, optimization, troubleshooting, qualification, and validation of methods such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (QDa, QQQ, TOF & QTOF), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods
  • Work experience analyzing monoclonal antibodies (mAb’s), oligonucleotides, RNA’s, and antibody drug conjugates (ADCs) is a huge plus
  • LC/MS method development for characterization of mAb’s, ADC and Oligo-antibody conjugates is plus.
  • Have worked on control strategies for large molecules for drug substance and drug products, phase appropriate national and international regulatory filing strategies
  • Able to develop and execute independently and/or collaboratively all aspects of analytical methods to support bio-conjugation team, process development, product development, in-process monitoring, stability studies for APIs/drug substances/bioconjugates including authoring and reviewing analytical methods, protocols, and reports for clients and stakeholders
  • Be a Subject Matter Expert for the team and support assay troubleshooting, investigations, and improving analytical methods and interpret complex data and perform statistical analysis using appropriate software
  • Ability to take on a leadership role and be strategic in proposing new technologies to improve process efficiency and increase capabilities
  • Plan and execute work on multiple projects simultaneously by collaborating with Chemistry, Bioconjugation, Process Development, Project Management and NJ Bio’s clients on clinical stage APIs/ADCs
  • Exhibit strong departmental leadership for best practices of technique, instrumentation, regulatory strategy, project management, processes, information organization, and communication
  • Ability to lead and work collaboratively as part of a team, and have prior experience with training, mentoring, supervising personnel and be a role model for 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
  • Communicate effectively with supervisors, colleagues, clients, and vendors

Education and Experience Requirements

Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, or related areas with over 4-6 years proven track record industry experience or Post Doc in Chemistry with over 3 proven track record in analytical method development, project leadership and problem solving in the pharmaceutical or biotech industry.

Email To Apply – jobs@njbio.com

Bioconjugation

Associate Scientist/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 0-5 years’ industry experience.

Email To Apply – jobs@njbio.com


Scientist

Job Responsibilities

Under minimal 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 plan and execute work on multiple projects simultaneously.
  • Ability to mentor others.
  • Ability to be an individual contributor.
  • 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

Ph.D. in Biochemistry, Protein Chemistry or other related field with 0- 2 years industry experience or M.S. in Biochemistry, Protein Chemistry, or other related field with 3-5 years’ experience.

Email To Apply – jobs@njbio.com

Quality

Urgently hiring for a R&D Quality Assurance Director:

We are looking for a R & D Quality Assurance Director to support establishment of a new cGMP manufacturing facility for clinical supplies (Phase 1 and 2 studies) for pharmaceutical and biotech clients in the ADC and small molecules space. This role has great potential to grow into a senior leadership role in the organization.

Job Responsibilities

  • Participate in the design and planning for R&D cGMP manufacturing suites.
  • Establish phase appropriate quality systems to support phase 1 and phase 2 clinical phase manufacturing of small molecule APIs, antibody-drug conjugate (ADC) drug substances, and ADC drug product.
  • Ensure that all applicable phase appropriate quality guidelines and regulations are followed, as appropriate for preclinical, tox, and phase 1 and 2 clinical manufacturing.
  • 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
  • Be the senior management representative in meetings with clients, vendors, and regulatory agencies.
  • Review and approve critical quality documents such as batch records, CofAs for release of materials & stability samples in GMP.
  • Oversee administration of GMP and non-GMP documents and 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 Analytical leadership to ensure that manufacturing, laboratory, facilities, analytical activities, 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 to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Skills

  • Have experience to lead a 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.

 Education and Experience Requirements

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

Email To Apply – jobs@njbio.com


QC Scientist (I, II, III, IV, Senior, Principal)

Job Responsibilities

  • Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
  • Work with management and vendors to acquire, install, and qualify new equipment.
  • Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
  • Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
  • Analysis of raw materials, in-process samples, finished products and stability samples by various analytical instruments 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

  • BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
  • 0-10 years of experience in a GMP manufacturing or CRO setting.

Email To Apply – jobs@njbio.com

Business Development

Proposal Manager, Synthetic Chemistry and Bioconjugations

NJ Bio is currently seeking to hire a Proposal Manager with a chemistry background 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.
  • 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 0-1 years of experience, MS or BS with 2-5 years of industry experience will be considered.
  • Prior work experience in industry, preferably in a CRO/CDMO, is desirable.
  • 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.
  • Highly self-motivated to join a fast-paced company and has willingness to learn on the job.

Job Type: Full-time

Email To Apply – jobs@njbio.com