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 the leading medical research center in the world.  We have an opening for a Senior Scientist (Downstream Process Development) to work on-site at the National Institutes of Health (NIH) in Gaithersburg, MD.

This is a long-term contract position which offers:
–    Competitive compensation and comprehensive benefit package
–    Optional health, vision, and dental plans
–    Paid leave as well as 11 paid federal holidays and 401K plan.  
–    Access to NIH’s unparalleled resources and niche scientific initiatives

KEY TASKS
(1) Oversee the development of downstream processes for clinical candidates and the process of tech transfer for clinical material generation
(2) Provide project support to develop downstream process methods that meet the product quality and recovery characteristics to guarantee successful production of clinical material.
(3) Serve as a subject matter expert (SME) in guiding purification strategies for new vaccine or therapeutic mAb candidates 
(4) Work with regulatory team to support IND submissions and other requests. 
(5) Oversee viral clearance strategies in relevant downstream processes and direct the viral clearance validation efforts 
(6) Plan and oversee downstream processes for toxicology lot material production. 
(7) Coordinate with manufacturing teams to ensure timely and scale-appropriate Technology Transfer is achieved
(8) Write/edit/review tech transfer documents to support downstream process Master Batch Record authoring.
(9) Serve as SME in downstream troubleshooting and facility fit calculations. 
(10) Serve as the Center’s downstream SME in external collaborations for clinical development projects
(11) Work to troubleshoot and improve downstream methods during the development cycle. This includes efforts in designing optimization studies (DOE with JMP) and streamlining efforts to ensure timely development schedules

REQUIREMENTS
(1) Ph.D. in Bioengineering, Chemical Engineering, Biochemistry, or a related field
(2) Minimum of 8 years of relevant experience with recombinant protein purification development for GMP clinical-phase products

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.

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. In addition, this position offers employees the ability to earn up to 160 hours of paid time off annually and eleven paid holidays per benefit year. We also offer a generous defined 401(k) contribution to help you save for retirement. 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.
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