Senior Scientist

Overview: ORAU has a contingent job opportunity for a Senior Scientist. This position will support of the overall functions of the Vaccine Production Program at the Vaccine Research Center. The position is contingent on award of an upcoming contract with NIAID Professional, Scientific and Technical Support Services. Salary for positions will be determined based on education and experience. Relocation support is not available for this position.
ORAU has been providing scientific and technical talent staffing solutions and designing, managing, and evaluating jobs and internships for more than 70 years. ORAU assists in connecting the best and most diverse group of students, recent graduates, faculty and professionals with world-class fellowships, internships and job opportunities, whether in national laboratories, research institutions, federal government offices or private sector R&D departments. Responsibilities: Senior Scientist
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.
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. Qualifications: Ph.D. in Chemical Engineering, Biology, Chemistry, or related Life Sciences field. o 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:
o Column chromatography for protein purification by means of AEX, CEX, affinity, SEC, HIC
o Column packing and testing
o AKTA chromatography system
o Lab scale TFF systems
o Lab scale nano-filtration systems
o Qualitative assays including SDS-PAGE and Western Blot
o 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).