Sr. Cell Culture Tech Transfer Scientist

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with leading medical research centers, biotechnology and pharmaceutical development companies in the world. We are seeking individuals qualified to work as a Sr. Cell Culture Tech Transfer Scientist to support the mission of the National Institutes of Health (NIH).

This is a long-term contract position which offers:

• Competitive compensation and comprehensive benefit package
• Optional health, vision, and dental plans
• Vacation leave as well as 10 paid federal holidays and 401K plan.
• Access to NIH’s unparalleled resources and niche scientific initiatives

Duties Include:

• Conduct upstream process development and tech transfer of production processes toward clinical manufacturing of VRC vaccine and antibody clinical candidates within the Cell Culture Development group at the VPP
• Provide subject matter expertise to lead scientists and/or associates to develop upstream process methods that meet the productivity and product quality characteristics to achieve successful production of clinical material. Including:
• Designing optimization studies (e.g. DOE with JMP)
• Use of high-throughput automated AMBR
  15 and AMBR
  250 bioreactors
• Use of fed-batch bench scale bioreactors and scalable Single-Use-Bioreactors SUBs at 50 L (supporting 250 L, 1000 L, and 2000 L manufacturing vessels)
• Develop pDNA production platform using microbial cell cultures in both shake flask and controller-programmed stirred-tank bioreactor formats.
• Collaborate with Project Managers to ensure upstream development milestones are appropriately set and met on time.
• Serve as a subject matter expert (SME) in guiding cell culture strategies (media/feed evaluation, control parameter tuning, etc.) for new vaccine or therapeutic mAb candidates (both mammalian and microbial cultures).
• Responsible for process evaluation/finalization and oversight of process-locked scale up runs to generate material for toxicology studies. Including, editing/approving/execution of process protocols and production reports.
• Coordinate closely with Manufacturing teams to ensure timely and scale appropriate Technology Transfer is achieved, by pursuing of the following:
• Write/edit/review tech transfer documents (Process Descriptions/Process Flow Diagrams)
• Serve as Person in Plant or assign designee for initial VCMP production runs.
• Serve as SME in VCMP upstream troubleshooting and facility fit evaluations.
• Serve as the VRC upstream SME in external collaborations.
• Generate necessary regulatory docs to enable IND submissions, FDA response, etc.
• Optimize lab operational space, in collaboration with Process Team Operations Manager and VPP Scientific Operations group, to implement and sustain an optimal productive lab environment (e.g. 5S organizational efforts, KANBAN, or other structural initiatives).
• Encourage and drive innovation to meet new upstream challenges and seeks to publicly distribute novel technologies through presentations at national conferences and/or publication in peer-reviewed journals.

Requirements:

• PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline.
• Minimum of eight (8) years of experience microbiology/or cell culture research and development.

PLEASE APPLY ONLINE

When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.

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It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.

You should know:
Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors