Principal Scientist, Cell Culture Process Development

Kelly; Bethesda (MD); On-site; USD 150,000 - 190,000; Full time

Job summary

Kelly Government Solutions is seeking a Principal Scientist, Cell Culture Process Development to support NIH in Bethesda, MD. The role leads development of cell culture processes for clinical candidates and enables tech transfer to clinical manufacturing.

The contractor will plan and conduct experiments, supervise lab activities, and collaborate with project teams to ensure regulatory readiness and timely delivery of results. A PhD and extensive culture experience are required.

Qualifications

• Ph.D. in Biochemistry, Chemical Engineering, or life sciences.
• Experience with mammalian and/or microbial cell culture development.
• Proficiency with Microsoft Outlook.

Responsibilities

• Supports the planning and execution of research experiments in the context of the laboratory's overall research program.
• Lead development of cell culture processes for clinical vaccine or therapeutic candidates, including process tech transfer for clinical grade material manufacture to enable clinical trials.
• Plan, design, and maintain execution of experiments that develop robust processes for toxicological grade material generation and scalable cGMP production.
• Serve as SME for tech transfer deliverables, regulatory submissions, and project planning.
• Establish production processes for cell culture workflows using advanced bioreactor systems and complex growth strategies.
• Drive innovation and adoption of new technologies (e.g., scalable tangential flow filtration-based transient transfection methods).
• Maintains laboratory equipment and the training of others in their use.
• Drive an upstream/cell culture project from conception to clinical manufacturing by developing processes requiring operation of bioreactors and other cell culture equipment and provide support as required.
• Maintains laboratory staff on research projects and techniques.
• Capture process development study results and process descriptions and results in lab notebooks and other technical documents to drive SOP generation, project review, and approval.
• Coordinates with junior staff to modify research protocols.
• Work with Principal Investigators in scheduling and prioritizing instrument usage.

Skills

Cell culture development

Mammalian & microbial culture

Education

PhD in life sciences

Tools

Outlook

Job description

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Principal Scientist, Cell Culture Process Development with the National Institutes of Health.

This is a long-term contract position which offers:

• Competitive compensation and comprehensive benefit package
• Optional health, vision, and dental plans
• Paid leave (min 120 hours; prorated for part-time position) as well as 11 paid federal holidays and 401K plan.
• Access to NIH’s unparalleled resources and niche scientific initiatives. Learn more about what Kelly can do for you at https://government.kellyservices.us/

TASKS. The contractor shall:

• Supports the planning and execution of research experiments in the context of the laboratory's overall research program.
• Lead development of cell culture processes for clinical vaccine or therapeutic candidates, including process tech transfer for clinical grade material manufacture to enable clinical trials. 1
• Plan, design, and maitain execution of experiments that develop robust processes for toxicological grade material generation and scalable cGMP production.
• Serve as subject matter expert (SME) for tech transfer deliverables, regulatory submissions, and project planning. 2
• Establish production processes for cell culture workflows using advanced bioreactor systems and complex growth strategies. 3
• Drive innovation and adoption of new technologies (e.g., scalable tangential flow filtration-based transient transfection methods). 4
• Supports laboratory staff on research projects and techniques.
• Maintatin upstream project schedules for cell culture through coordination with project management, cell line development, and downstream processing groups.
• Maintains laboratory equipment and the training of others in their use.
• Drive an upstream/cell culture project from conception to clinical manufacturing by developing processes requiring operation of bioreactors and other cell culture equipment and provide support as required.
• Assists in maintaining adequate space and facilities for ongoing and projected research studies.
• Manage scientific equipment and resources (e.g. reagents, stocks of frozen sells, animal samples) including acquisition, documentation and storage.
• Participate in the laboratory’s review of future proposals for resource allocations. Evaluates, analyzes and interprets research data, communicates results and methods in reports, presentations, and manuscripts.
• Participate in project and laboratory meetings, keep current with compliance obligations, and be responsible for maintenance of the laboratory and equipment
• Capture process development study results and process descriptions and results in lab notebooks and other technical documents to drive SOP generation, project review, and approval.
• Coordinates with junior staff to modify research protocols.
• Work with Principal Investigators in scheduling and prioritizing instrument usage. Presents research at national scientific meetings and symposia.
• Research and implementation of industry-leading technologies to optimized cell culture systems and methodologies.
• Investigate in-depth cell culture science and apply results to improve overall processes for VPP production runs.
• Provides interpretation of results, guidance, and scientific support to the management team.
• Capture process development study results and process descriptions and results in lab notebooks and other technical documents to drive SOP generation, project review, and approval.

REQUIREMENTS. The contractor must have:

• Ph.D. in a Biochemistry, Chemical Engineering, or other life sciences
• Software: Outlook
• Skills: 15 years of experience in mammalian and/or microbial cell culture development

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, short-term disability, and a transportation spending account. Visit https://www.mykelly.us/us-mykelly/perks/ for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.