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. Apply process optimization techniques, such as Design of Experiments (DoE) or other
statistical design approaches. Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in
support of other groups at the VRC. 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
oversee viral clearance chromatography and filtrations processes. Work collaboratively with all VPP departments to coordinate schedules, material needs, and
other deliverables to advance site-wide project goals. Analyze and compile data, present at various group/department meetings. Represent the VPP at external conferences, workshops, and/or seminars. Write and review process batch records for toxicology batch productions. Write and 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. Specific Qualifications: Ph.D. in Chemical Engineering, Biology, Chemistry, or related Life Sciences field.
M.S. degree with 6 years relevant experience is also acceptable. 2-10 years of experience in industry-relevant recombinant protein 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 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). To Apply: You can submit your resume or CV direct to our website at: Senior Scientist in Gaithersburg, Maryland | Careers at NIAID Gaithersburg, MD (icims.com)
The deadline for this application is August 20, 2021.
If you have any questions please email our Lead STEM recruiter at [email protected]