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Senior Scientist (Downstream Process Development

Job in Gaithersburg, Montgomery County, Maryland, 20883, USA
Listing for: Kelly
Full Time position
Listed on 2026-08-22
Job specializations:
  • Research/Development
    Research Scientist, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 150000 - 200000 USD Yearly USD 150000.00 200000.00 YEAR
Job Description & How to Apply Below
Position: Senior Scientist (Downstream Process Development)

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. We have an opening for a Senior Scientist (Downstream Process Development) to work on-site at the National Institutes of Health 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
  • #J-18808-Ljbffr
    Position Requirements
    10+ Years work experience
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