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No Open Roles At This Time

No Open Roles At This Time

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Sr. Manager/ Associate Director, Facilities & Engineering

Job Summary

The Sr. Manager/ Associate Director, Facilities & Engineering will provide technical and engineering support for critical utilities and facilities used in GMP manufacturing. This role will lead the design, implementation, and maintenance of new and existing utility systems, ensuring reliable and compliant operations that support pharmaceutical manufacturing and product quality. He/ she will collaborate cross-functionally with Facilities, Engineering, Manufacturing, Quality, and external vendors to optimize systems performance, resolve technical issues, and drive continuous improvement in facility and utility operations. The incumbent works cross-functionally with internal departments and external resources on facilities and engineering related issues. The Sr. Manager/ Associate Director, Facilities & Engineering supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Lead the design and layout of plant systems, utilities, and manufacturing areas including clean utilities and high potent containment (e.g., cleanrooms, process suites, utilities and solvent storage and handling).
• Plan, coordinate, and execute engineering analysis related to pharmaceutical plant operations and process/equipment optimizations. Develop strategy and processes to support 24X7 operations, including troubleshooting and optimization of equipment operational issues, preventive maintenance and system upgrades.
• Interface with stakeholders, vendors, and contractors to align designs and current operations with technical requirements and operational schedules.
• Provide technical expertise in clean and plant utilities, including HVAC, WFI, autoclaves, purified water, clean steam, and clean gas systems.
• Develop, update and review engineering documentation such as design specifications, P&IDs, User Requirements, Functional Specifications, protocols (FAT/SAT/IQ/OQ/PQ), SOPs, and reports.
• Plan and execute preventive and corrective maintenance programs for utility and facility systems.
• Serve as subject matter expert (SME) in the areas of plant utilities, facilities, engineering and manufacturing equipment.
• Lead identification, root cause and resolution issues, including all aspects of deviation investigations, change control, and CAPAs.
• Monitor utility performance through data analysis, statistical methods, and reliability assessments.
• Collaborate with internal and external stakeholders to ensure systems meet technical, operational, and GMP compliance standards.
• Act as a liaison between the Facilities & Engineering team, manufacturing operations, and quality departments.
• Ensure all activities adhere to FDA, EMEA, GMP, OSHA, and other applicable regulatory requirements.
• Support continuous improvement projects to enhance system performance, energy efficiency, and reliability.
• Ensure building operations comply with all local building codes, zoning laws and regulations.
• Establish and maintain relationships and contracts with external vendors.
• Review fixed asset inventory and update as required.
• Maintain site compliance related to environment, health, and safety.
• Develop and implement processes necessary to operate the facility, including non-GMP cleaning/housekeeping, badging/security, and pest control.
• Make recommendations to promote efficiencies and apply a proactive approach to potential operational/environmental hazards/risks.
• Manage projects in support of space planning and expansion across all locations to meet hiring requirements.
• Develop and maintain budgets and long-range facilities plans based on company growth and future needs.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• In-depth understanding and knowledge of clean utility systems (WFI, purified water, clean steam, clean gases) and plant utilities (HVAC, boilers, chilled water, cooling towers, process chillers).
• Knowledge of GMP, FDA, EMEA and OSHA standards applicable to pharmaceutical manufacturing.
• Ability to interpret and develop engineering drawings (P&IDs, equipment layouts, GA drawings).
• Requires relevant work experience in Utilities Systems, Facilities equipment, Building Management/Control Systems (BMS), design, build and operational support.
• Must have strong attention to technical details including engineering life cycle principles, with strong mechanical, instrumentation, electrical and process hands on capabilities.
• Strong troubleshooting and problem-solving skills with a focus on root cause analysis.
• Excellent technical writing and documentation skills.
• Strong collaboration, project management, and communication abilities.
• Mechanical, electrical, and process systems hands-on capabilities.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as required to fulfill business needs.

Education and Experience Requirements

• Bachelor’s degree in Mechanical, Chemical, Biochemical, or Engineering Technology, or related field.
• 10+ years of relevant engineering or facilities experience.
• Minimum of 5 years of GMP experience preferred.

Physical Demands

• Ability to stand, walk, sit, reach, climb, balance, stoop, kneel, crouch, or crawl as required.
• Ability to lift and/or move up to 40 pounds.
• Requires hearing, vision, and speaking within normal ranges for communication and inspection activities.

Working Conditions

• Mechanical Spaces including close proximity to boilers and HVAC systems.
• Laboratory/Manufacturing environment including areas with high potent materials.
• Outside

Certificates & Licenses Required

N/A

Compensation

$120,000- $180,000 per annum

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Assistant Project Manager

Job Summary

We are looking for a dedicated and detail-oriented Assistant Project Manager to join our team. The successful candidate will be responsible for supporting project management activities, ensuring projects are completed on time, within scope, and on budget, while maintaining high levels of customer satisfaction and collaboration. This position requires it to be onsite the vast majority of the time. The incumbent works cross-functionally with internal departments and external resources on project management related issues. The Assistant Project Manager supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Communicate with external clients and internal stakeholders, coordinate meetings, conduct meetings, record meeting minutes, and organize and store meeting files and documents in designated locations.
• Develop and manage a detailed project schedule and work plan, tracking project scope, timelines, status, and budget to ensure on-time and on-budget delivery of projects. Adjust timelines as needed.
• Keep clients and project teams updated with progress reports and up-to-date information on the project.
• Collaborate with the 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 the entire project execution.
• Develop and maintain strong collaborative working relationships and interact effectively with all levels within the organization and with external clients.
• In emergency cases (During GMP operations), the employee is expected to be available virtually or in some cases onsite, during holidays, weekends, and early/late hours.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• Outstanding interpersonal skills with a demonstrated ability to effectively build positive working relationships across functions.
• Well-versed in basic project management principles, including identifying critical paths, building and communicating timelines, defining milestones, and setting expectations and accountability.
• Self-motivated with a willingness to grow and learn new skills.
• Proficiency in MS Project is recommended.
• Proficiency in using Smartsheet for project management is a plus.
• May occasionally require working beyond regular business hours to accommodate international clients.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

Education and Experience Requirements

• BS, MS, or PhD in Chemistry, Biochemistry, Biology, Health Sciences, or other related disciplines is a plus.
• Analytical R&D and QC experience is a plus.
• PMP Certificate is a plus.
• Smartsheet experience is a plus.

Physical Demands

N/A

Working Conditions

Office based position.

Certificates & Licenses Required

PMP Certificate is a plus

Compensation

$65,000- $68,000 per annum

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*We kindly request that agencies and recruiters do not contact us regarding this position.

Biophysics Strategic Manager

Job Summary

The Biophysics Strategic Manager has a background in life sciences and plays a crucial role in driving a company’s growth and profitability via the expansion of NJ Bio’s offerings to include biophysics and related technical capabilities. The candidate will conduct and/or manage laboratory experiments, build molecular models, and use advanced techniques to develop medicines and improve biotechnologies. They will help grow biophysics capabilities by seeking, managing and overseeing client relationships relating to their expertise. They will also oversee laboratory personnel, maintain safety standards, and ensure adherence to relevant regulatory requirements and Company Standard Operating Procedures as appropriate.

Job Responsibilities

Primary responsibilities:

• Develop and manage a Biophysics-focused CDMO unit and facilitate its integration and collaboration within the existing NJ Bio business infrastructure.
• Seek and build clientele for Biophysics and other NJ Bio offerings.
• Provide strategic and technical oversite to all aspects of the new capability: initial client engagement, project strategy and literature review, experimental design and execution, data analysis and interpretation, and reporting.
• Create workflows for extensive biophysical characterization of multiple therapeutic modalities including small molecules, peptides, fragments, biologics, and antibody-based molecules (antibodies, ADCs, bispecific antibodies, VHH nanobodies, etc).
• Identify new opportunities: Exploration of markets, trends, clients and partnerships to find business growth opportunities.
• Relationship Management: Build and maintain strong relationships with clients and partners.
• Support Business Development (Proposal Management) with the preparation of quotes and proposals.

Secondary responsibilities:

• Prepare scientific documents, presentations, and business development materials for trade shows and conferences.
• Support Business Development team members with contracting, confidentiality, and related legal agreements, as needed.
• Performs other related tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• Extensive knowledge of protein expression, purification, QC, biophysics, structural biology, with proficiency in assessing protein folding, size, oligomerization, activity, thermal stability and developability profiling.
• Demonstrated expertise in the use of biophysical methods (SPR, MST/SpS, DSF/nDSF, GCI, CD, DSC, NMR for characterization of biomolecular interactions of various therapeutic modalities (protein-small molecule conjugates, protein-protein, etc).
• Strategic Thinking: Ability to develop long-term business strategies.
• Negotiation: Skilled in negotiating contracts and proposals with clients and service providers.
• Communication: Strong interpersonal and effective communication skills for interacting with site personnel, clients, customers, and prospects.
• Ability to perform work with high level accuracy and keen attention to detail.
• Demonstrated willingness to learn and grow technical and business skills and abilities.
• Strong organizational and time management skills with the ability to multitask in a fast-paced environment.
• Proficiency with Microsoft Office
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Education and Experience Requirements

• PhD in chemistry, biochemistry, biology, biophysics, structural biology or related life science discipline.
• Minimum of 3+ years prior work experience, preferably in a CRO/CDMO or biotech/biopharma.

Physical Demands

• Could require lifting 40 lbs and standing up for long stretches of time.

Working Conditions

• Occasional business travel to trade shows, conferences, or client meetings (≤ 25%).
• General laboratory environment, office environment or home office.

Certificates & Licenses Required

N/A

Compensation

$110,000-$130,000 per annum

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No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

*We kindly request that agencies and recruiters do not contact us regarding this position.

Scientist/ Senior Scientist, In vivo & Preclinical Translational Research

Job Summary

We are seeking a highly motivated Scientist/ Senior Scientist to lead and support in vitro and translational biology studies for preclinical and IND-enabling research programs. This role is ideal for a PhD-level/ Masters level scientist with strong hands-on laboratory experience and a working understanding of animal research supported translational studies, particularly in oncology, biologics, or antibody-drug conjugates (ADCs). The incumbent works cross-functionally with internal departments and external resources on in vitro and translational research related issues. The Scientist/ Senior Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. This role requires hands-on involvement in both in vitro and in vivo studies, including significant animal work in support of translational research programs.

Job Responsibilities

• Actively support and participate in in vivo studies, including extensive hands-on animal work (rodent models), dosing, monitoring, and tissue collection in alignment with study protocols.
• Design, execute, and interpret in vitro and translational assays supporting preclinical decision-making
• Lead cell-based assays including cytotoxicity, viability, binding, internalization, and mechanism-of-action studies
• Develop, optimize, and troubleshoot in vitro assays
• Collaborate with in vivo/animal research teams to align in vitro and in vivo findings
• Support sample strategy, tissue handling, and downstream biomarker analyses
• Analyze data and prepare study summaries, reports, and sponsor-facing presentations
• Ensure work follows GLP-like practices, SOPs, and data integrity standards
• Mentor junior scientists and contribute to SOP development
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• Extensive hands-on experience with animal (rodent) studies, including dosing, sample collection, and study execution.
• Experience in a preclinical CRO environment or working closely with CROs on in vivo studies is strongly preferred.
• Proven ability to design experiments, analyze data, and communicate results clearly
• Proficiency with Microsoft Office
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Education and Experience Requirements

Required:

• PhD in Biology, Biotechnology, Biomedical Sciences, Pharmacology, or related field

OR

• Master’s/ Bachelor’s degree in Biology, Biotechnology, Biomedical Sciences, Pharmacology, or related field with equivalent experience.
• Strong hands-on experience with cell culture and in vitro assays.
• Experience in a preclinical, translational, CRO, biotech, or pharmaceutical environment.
• Experience:

     Scientist: 2–4 years of experience
     Senior Scientist: Minimum 8 years of experience

Preferred:

• Experience supporting or collaborating on animal (rodent) studies.
• Background in oncology, biologics, or antibody-drug conjugates (ADCs).
• Experience with flow cytometry, ELISA/Luminex, or imaging-based assays.
• Prior involvement in IND-enabling or regulatory-facing studies.
• CRO or sponsor-facing experience.

Physical Demands

N/A

Working Conditions

Laboratory and office environment

Certificates & Licenses Required

N/A

Compensation

Scientist-$55,000 to 75,000 per annum

Senior Scientist-$88,000 to 110,000 per annum

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*We kindly request that agencies and recruiters do not contact us regarding this position.

Vivarium/ Animal Care Technician

Job Summary

We are seeking a motivated Vivarium/ Animal Care Technician to support preclinical and translational research studies. This role involves hands-on animal care, maintaining accurate records, ensuring clean animal facilities. The incumbent works cross-functionally with internal departments and external resources on such related issues. The Vivarium/ Animal Care Technician supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Daily husbandry of laboratory rodents (primarily mice and rats), including:
  Feeding, watering, cage changing, and sanitation.
• Maintaining accurate animal care and vivarium records.
• Cleaning and maintaining animal rooms, equipment, and work areas.
• Following all IACUC, institutional, and safety protocols.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• Ability to follow SOPs and regulatory requirements.
• Comfortable handling mice and rats.
• Strong attention to detail and willingness to follow strict protocols.
• Reliable, punctual, and responsible
• Proficiency with Microsoft Office
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Flexibility to work on a rotational weekly-off schedule, including mandatory weekend work as required by business needs.

Education and Experience Requirements

Required:

• High school diploma
• 1–2 years of experience in laboratory animal care (rodents required)

Preferred:

• Experience working in an academic or research vivarium.
• Familiarity with basic animal health indicators.
• IACUC or institutional animal care training (or willingness to complete training)

Physical Demands

N/A

Working Conditions

Laboratory and office environment

Certificates & Licenses Required

N/A

Compensation

$28 to $30 per hour

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No Open Roles At This Time

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