Operations Specialist

Overview

We seek an 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.

Downstream: 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.

Purification: Separation of contaminants closely imitating the product in physical and chemical properties.

• Prepare buffers pour columns with specific resins, lyses cells to homogeneous suspensions.
• Perform extractions of cells and cell products.
• Use column chromatography, centrifugation, and other techniques to purify vaccine materials.
• Make recommendations for the purification of desired products based on research data received from research personnel.
• Responsible for all types of purification and downstream processing and the use of various equipment to meet these goals.
• Perform various analytical procedures to characterize and quantitate the product at all steps in the purification process.

Fill Finish: Filling, Formulation and Lyophilization of desired products.

• Perform scheduling of filling/lyophilization of desired products.
• Perform bulk thaw, dilution, and formulation operations.
• Set up equipment/machines aseptically for proper operation, including installing and disassembling equipment and parts required for filling and formulation operations.
• Perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
• Operate cleanroom equipment aseptically and efficiently (lyophilizer, manual and automated filler equipment, vial washer, part washer, autoclave, labeler, and dehydrogenation oven).
• Perform full-scale lyophilization of vaccine lots, including monitoring cycle parameters while in process.
• Perform labeling of final product vials.
• Operation and non-contract maintenance of the filling machines, freeze-dryer, and sterilization equipment; preparation of all glassware, reagents, and materials that are used for a filling operation.

General Duties:

• Adheres to current Good Manufacturing Procedures (cGMP)…