Downstream Process Development 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 Downstream Process Development 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:

• 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 Nano System, Inc Ignite and Blaze, and/or Knauer Nano Scaler 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.

Requirements:

• 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.

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 a specialty talent company, Kelly is committed to doing the right thing for our talent and clients.

We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s next.

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