Overview
CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.
CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today!
We are seeking a Downstream Process Development Scientist to support the mission of the Vaccine Production Program (VPP) at the National Institutes of Health (NIH) to:
Responsibilities
- Support the Downstream Process Development (purification) group of the Vaccine Production Program (VPP) at the Vaccine Research Center.
- Develop downstream processes, with minimal supervision, for recombinant proteins such as monoclonal antibodies, subunit or nanoparticle vaccines, and virus-like particles (VLPs) that may be used as clinical therapeutic or vaccine candidates.
- Work independently and collaboratively within the purification group to design, develop and optimize chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes for all clinical trial vaccine candidates.
- Apply process optimization techniques, such as Design of Experiments (DoE) or other statistical design approaches
- Serve as a functional lead and/or Subject Matter Expert (SME) in an inter-department Chemistry, Manufacturing, and Control (CMC) team with responsibilities for the following processes: chromatography, depth filtration, nano-filtration, and tangential-flow filtration (TFF)
- Train associate scientists in the execution of chromatography and filtration processes.
- Support Viral Clearance Validation studies by traveling to CMO/CRO sites to perform and/or oversee viral clearance chromatography and filtrations processes.
- Work collaboratively with all VPP departments to coordinate schedules, material needs, and other deliverables in order to advance site-wide project goals.
- Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in support of other groups at the VRC.
- Analyze and compile data, present at various group/department meetings.
- Represents the VPP at external conferences, workshops, and/or seminars.
- Pursue novel technologies to advance the capabilities of the VPP.
- Write and/or review process batch records for toxicology batch productions.
- Write and/or review technology transfer documents in support of GMP manufacturing.
- Write and/or review appropriate CMC sections of IND filings (e.g. Process Description Summaries) to support VRC regulatory group.
Qualifications
- Ph.D. in Chemical Engineering, Biochemistry, Chemistry, or related Sciences field with Six (6) years of relevant experience.
- M.S. degree with ≥10 years relevant experience will also be considered.
- Four (4) to Ten (10) years of experience in industry-relevant recombinant protein downstream process development for GMP clinical-phase products.
- Demonstrated knowledge of maintaining accurate and detailed records.
- Demonstrated expertise in the following techniques or tools for protein purification and characterization:
- Column chromatography for protein purification by means of AEX, CEX, affinity, SEC, HIC
- Column packing and testing
- AKTA chromatography system
- Lab scale TFF systems
- Lab scale nano-filtration systems
- Qualitative assays including SDS-PAGE and Western Blot
- UV/vis spectrophotometer
- Previous work experience in a GMP environment in biotech/pharmaceutical industry.
- 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.
- Knowledge and use of statistical design of experiments (DoE).