The Vaccine Production Program at National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA is looking for a scientist in downstream process development division. A doctoral degree with 2+ years of relevant experience is preferred.
National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Bethesda, MD 20852
TASKS/SERVICES. The contractor shall:
• 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 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 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.
CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. The contractor must have:
- Ph.D. in Chemical Engineering, Biology, Chemistry, or related Life Sciences field.
- M.S. degree with ≥6 years relevant experience will be considered.
- 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 crossfunctional 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).
PLACE OF PERFORMANCE
The place of performance is NIAID/VRC 9 West Watkins Road Gaithersburg, MD.
This work may also be performed remotely at the discretion of the IC, NIAID.
Work will be performed up to 40 hours per week during normal business hours, Monday-Friday, excluding Federal holidays.
Eligible candidates should message Krishna Gulla on LinkedIn: https://www.linkedin.com/in/krishna-gulla-2883046/