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