Kelly · 18 hours ago
Downstream Process Development Scientist
Kelly Government Solutions is a strategic supplier and business partner to the federal government, seeking a Downstream Process Development Scientist to support the National Institutes of Health (NIH). The role involves developing downstream purification processes for clinical candidates and collaborating with various teams to optimize and transfer processes for clinical manufacturing.
Responsibilities
Develop downstream (purification) processes, under the supervision of a project lead scientist, for recombinant proteins, virus vaccines, and virus-like particles (VLP) that may be used as clinical candidates
Design and execute mRNA-Lipid Nanoparticle (LNP) process development studies for mRNA-lipid nanoparticle encapsulation
Serve as SME with operation and optimization of microfluidic systems, e.g. Precision NanoSystem, Inc Ignite and Blaze, and/or Knauer NanoScaler Impingement Jet Mixers
Develop scale down and scale-up operations to advance tech transfer to manufacturing and/or enable troubleshooting
Screen and optimize tangential flow filtration processes for mRNA-LNP products to generate preclinical materials and drive tech transfer for clinical manufacturing
Design and execute lipid screening studies to evaluate novel lipid components and formulations for use in pre-clinical safety and efficacy studies
Collaborate with analytical and formulation scientist to characterize mRNA-LNP formulations and optimize process flows and sample stability
Perform in vitro transcription reactions to generate mRNA products
Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in collaboration with other groups or external collaborators
Work within the purification group to design, develop and optimize chromatography and filtration step unit operations to drive process development of clinical trial vaccine candidates and mAb products
Collaborate with project management to ensure mRNA-LNP development milestones and study deliverables are met in a timely manner
Work to prepare necessary materials (buffers, packed columns, etc.) for execution of downstream process activities
Perform technology transfer of processes to VRC Pilot Plant for manufacture of clinical product through document generation and on-site support
Write and review tech transfer documents, technical protocols and reports
Generate supporting documents, as necessary, for IND-filings and other regulatory needs
Analyze and compile data, present at various group/department meetings
Qualification
Required
Bachelor's degree in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline
5-7 yr experience in recombinant protein purification and mRNA-LNP development for GMP clinical-phase products
Demonstrated knowledge of maintaining accurate and detailed records
Must be a team player who can effectively work with members from cross-functional departments
Strong oral and written communication skills
Familiarity with computer software including word processing and data evaluation
Benefits
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
Company
Kelly
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H1B Sponsorship
Kelly has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (85)
2024 (76)
2023 (59)
2022 (74)
2021 (81)
2020 (65)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
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