Senior Bioprocess Specialist

Overview

We are seeking a Senior Bioprocess Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaged 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 diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Responsibilities

• Author standard operating procedures and record revisions.
• Draft deviations, CAPAs, change controls, and lead investigations, ensuring they are closed before deadlines.
• Be responsible for cGMP equipment implementation, operation, maintenance, and training as assigned by the area manager.
• Cell expansion of microbial and mammalian cells from vial thaw to shake flasks, fermentors/bioreactors, and harvest using continuous centrifugation.
• Review and confirm cGMP using good documentation practices and in compliance with Quality Assurance compliance and good documentation practices for manufacturing documents, procedures, and records.
• Spot-clean the cGMP manufacturing area, leverage the aseptic technique, and use grade-appropriate personal protective equipment as required to maintain cGMP spaces within environmental monitoring compliance specifications.
• Communicate effectively and consistently with other departments.
• Manage cGMP project inventory and kanban inventory per site policies and procedures.
• Prepare media, buffers, single-use assemblies, and components as required.
• Process on-floor offline sampling using cGMP analytical equipment and materials.
• Generate manufacturing deep-dives, process summaries, run reports, and quality documentation as required by site policies and procedures.
• 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.
• Responsible for training other personnel on procedures and operations of equipment.
• Ensure that all data is entered in records to be maintained on file for each product.
• Maintain a safe workplace, ensuring awareness and observance of appropriate. safety and occupational health rules and regulations. The employee is required to attend safety training relative to their position and report any infractions of safety procedures to the facility Safety Officer.
• Perform light duties and other related duties as required and assigned, including working in other sections.
• Function as tech transfer lead on two or more projects.

Qualifications

• A BA/BS degree in science (preferably chemistry, biochemistry, biology, microbiology, or engineering) and 10+ years’ experience in a regulated laboratory environment or an equivalent combination of credentials and experience.
• Professional knowledge of the principles and practices applicable to the purification and downstream processing of materials for vaccines destined for early-phase clinical tri