Careers

No Open Roles At This Time

No Open Roles At This Time

Principal Scientist

Job Responsibilities

• Independently plan work for each project and execute it towards a timeline while maintaining productivity.
• Plan and execute chemical syntheses from milligram to hundreds of grams scales and conduct purification and characterization of compounds
• Liaise with purchasing to follow up on arrivals of materials and help procurement with selection of materials.
• Provide input on equipment purchases.
• Supervise Scientists, Associate and Sr. Associate Scientists; maintain performance management metrics for personnel.
• 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 lab support.
• 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 scientific writing and to listen actively with internal and external stakeholders.
• Ability to apply critical thinking and good problem-solving skills.

Education and Experience Requirements

Ph.D. in chemistry with over 5 years industry experience or M.S. in Chemistry with 10 plus years’ experience.

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Assistant Project Manager, R&D

About the job:

NJ Bio, Inc is a contract research organization (CRO) that provides chemistry and biopharmaceutical services specializing in bioconjugation, payload-linker synthesis, oligonucleotide synthesis and process development. The company is headquartered in Princeton, NJ with additional development facilities in Bristol, PA.

NJ Bio is currently seeking to hire an Assistant Project Manager with a background in Chemistry, Biochemistry, Biology, Health Sciences, or other related disciplines. This position requires excellent communication skills and the ability to simultaneously manage multiple clients and internal projects. The assistant project manager is responsible for helping the project management team communicate with clients, coordinate meetings, conducting meetings, recording meeting minutes, tracking project scope, timelines, and budget to ensure on-time and on-budget delivery of projects. This position requires to be onsite the vast majority of the time.

Responsibilities that the assistant project manager will assist the project management team with:

• Work in close collaboration with team leaders, group members, and functional/executive leadership to develop, execute and manage company’s projects.
• Track and inform for project management, project resources in an effective and efficient manner.
• Coordinate project deliveries to ensure the scope, quality, time, and cost objectives.
• Achieve a high degree of customer satisfaction with both internal stakeholders and external clients.
• Develop and manage a detailed project schedule, work plan, and track project timelines to ensure project is completed in a timely manner. Adjust timelines if needed.
• Keep client and project team updated with progress reports and up to date information on the project.

• Collaborate with Business Development team and contribute to their activities as needed.
• Partner with management to support safety and quality initiatives within the organization.
• Utilize industry best practices, techniques, and standards throughout entire project execution.
• Develop and maintain strong collaborative working relationships and interact effectively with all levels within the organization and with external clients.

Education, Experience, and Skills required:

• BS, MS, or PhD in Chemistry, Biochemistry, Biology, Health Sciences, or other related disciplines is a plus
• PMP Certificate is a plus
• Ability to work individually or collaboratively on multiple projects concurrently.
• Outstanding interpersonal skills with a demonstrated ability to effectively build positive working relationships across functions.
• Well versed in basic project management principles including, but not limited to, identifying critical paths, building, and communicating timelines, defining milestones and methods for setting expectations and accountability.
• Excellent written and verbal communication skills as well as outstanding organizational skills required.
• Self-motivated and willingness to grow and learn new skills.
• Proficiency in Microsoft SharePoint, Word, Excel, PowerPoint, and MS Project are recommended.
• Multi-tasking is critical skill.
• May occasionally require working beyond regular business hours to accommodate international clients.

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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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PRINCIPAL MANUFACTURING ENGINEER, cGMP CHEMICAL PROCESS DEVELOPMENT & BIOCONJUGATION

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

Job Responsibilities:

• Overseeing and training cGMP operators involved in manufacturing of clinical batches of ADCs, conjugates, mRNA, and small molecules and executing clinical batches
• 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
• Leadership and Execution of GMP, R&D and Clinical batch records with minimal or no supervision
• Authors and reviews GMP equipment Standard Operating Procedures (SOPs)
• Author, review, and approve Batch Records
• Lead 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 Requirements

• B.S./M.S. Chemical Engineering/Chemistry with 5-8 years’ experience of cGMP manufacturing in life science industry setting.
• High potency API manufacturing experience is needed.

Other Skills, Abilities, Qualifications:

• Organizational skills
• Ability to lead a team
• 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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No Open Roles At This Time

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:

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 Requirements:

• 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:

• 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.

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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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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PRINCIPAL MANUFACTURING ENGINEER, cGMP CHEMICAL PROCESS DEVELOPMENT & BIOCONJUGATION

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

Job Responsibilities:

• Overseeing and training cGMP operators involved in manufacturing of clinical batches of ADCs, conjugates, mRNA, and small molecules and executing clinical batches
• 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
• Leadership and Execution of GMP, R&D and Clinical batch records with minimal or no supervision
• Authors and reviews GMP equipment Standard Operating Procedures (SOPs)
• Author, review, and approve Batch Records
• Lead 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 Requirements

• B.S./M.S. Chemical Engineering/Chemistry with 5-8 years’ experience of cGMP manufacturing in life science industry setting.
• High potency API manufacturing experience is needed.

Other Skills, Abilities, Qualifications:

• Organizational skills
• Ability to lead a team
• 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.

Confirm Job Qualifier To Apply

No Open Roles At This Time

No Open Roles At This Time

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.

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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 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 3-5 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.

Work Experience 
 

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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No Open Roles At This Time

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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