Senior Scientist

Overview

We are seeking a Senior Scientist to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.

 

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs. 

 

Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.  

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.
• Develop/optimize scalable harvest and purification steps for plasmid DNA (pDNA) products from E.coli production runs to support reagent production lots and process tech transfer to clinical manufacturing.
• Work independently and collaboratively within the purification group to design, develop and optimize chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes.
• Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles, plasmid DNA, and/or other nucleic acid products 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, as well as any other process specific elements of plasmid purification.
• 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/VRC at external conferences, workshops, and/or seminars.
• Write and review process batch records for process representative development 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. 
• Performs other duties as assigned.

Qualifications

• Ph.D. in Chemical Engineering, Biology, Chemistry, or related Life Sciences field is required.
• More than five years of experience in industry-relevant recombinant protein process development for GMP clinical-phase products is required.
• 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.

Physical Requirements:

 

The physical requirements described here are representative of those that must be met by a candidate to perform the essential function