GMP Operations Specialist

We seek a GMP
Operations Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. The Operations Specialist will support manufacturing in the following areas Upstream, Downtime, Purification, and Fill Finish. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day.

Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.

CAMRIS International, LLC, is a dynamic medical research and 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 vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; 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.

Upstream:
Prepare cell culture for virus inoculation and prepare viral seeds.

• Provide input on cell culture, bioproduction and purification of mammalian cell-based products.
• Experience and knowledge of cGMP, specifically bioproduction of viral vaccines.
• Execute and participate in cGMP viral growth, virus vaccine purification for cGMP vaccine bioproduction.
• Aseptic gowning, aseptic processing, aseptic final filtration and working in a cleanroom environment.
• Cell culture experience (adherent cells a plus), washing and counting cells, repeated trypsin manipulations.
• Maintain virus vaccine bioproduction inventory, order equipment and reagents.

The downstream part of a bioprocess refers to the part where the cell mass from the upstream are processed to meet purity and quality requirements.

• Execute cell expansion of seeds and viral seeds as required.
• Manage and maintain manufacturing-owned controlled temperature units (CTUs) and incubators per site policies and procedures.
• Perform bioreactor setup, operation, maintenance, and cleaning per site policies and procedures.
• Prepare harvest equipment per SOP and batch record instructions per site policies and procedures.
• Execute cell lysis through chemical or physical (e.g., microfluidizer) cell disruption.
• Perform recovery mid-stream unit operations, including but not limited to depth filtration, centrifugation, and tangential flow filtration as required and per site policies and procedures.
• Pour resin, pack columns, verify HETP and Asymmetry, and equilibrate columns.
• Develop purification batch records and AKTA UNICORN methods as required.
• Analyze UNICORN and other downstream result files, attach per GDP to records, summarize data, and incorporate analysis into run reports as required.
• Sanitize, empty, and store columns per site policies and procedures.

* Please see the full job listing for additional responsibilities.

• Must have proficiency with various types of office software:
  Outlook, Word, Excel, MS Project; LIMS experience and experience with equipment monitoring systems are a plus.
• Must have the ability to follow directions, written policies, and procedures for work responsibilities.
• Licensed vaccinations might be required to work with certain viral agents.
• Must have good people and communication skills (written and verbal).
• Performs other duties as required.
• A bachelor's degree in a science field (preferably chemistry, biochemistry, microbiology, or engineering) and four+ years of industry experience performing cGMP production, downstream, purification, fill finish, and upstream in a clean room environment.
• Professional knowledge and experience requirements related to viral product safety for product release and downstream purification (chromatography) are a plus.
• Experience with aseptic gowning, aseptic processing, aseptic final filtration, and working in a cleanroom environment.
• Experience with bioproduction equipment: centrifuges, tangential flow filters, spectrophotometer, biosafety cabinets, sonicator, autoclave, roller bottles, a plus.
• cGMP experience for large-scale viral production of biological products is a plus.
• Working knowledge of disposable manufacturing methodologies, such as the use of sterile bags with tubing and tubing welders, is a definite plus.
• Hepatitis B immunity is required; vaccination will be provided if needed.
• Must be able to work independently following a brief period of specific technical training.
• Must have familiarity with related fields, such as general microbiology, physical chemistry, and biochemistry.
• Must have some knowledge of the operation of automated/manual filling machines,…