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.

• Support All‑stream operations activity, teaching others core department functions while contributing to at least three other operations areas.
• Configure, observe, report and respond to process values as a clinical manufacturing operator (considered R&D).
• Initiate and author deviations for out‑of‑specification results.
• Advise other SMEs and clients in the areas of specialized processes, aseptic technique, cell banking, TFF, and general bioprocess equipment technology, maintenance and operation.
• Author and review standard operating procedures and record revisions.
• Coordinate with and support manufacturing sciences and technology process characterization and development activities as required supporting advancement of phase 1 clinical manufacturing.
• Spearhead two or more complex tech transfer projects annually, leveraging deep bioprocess expertise to author comprehensive project plans and deliver technical unit operation deep‑dives.
• Lead high‑visibility project meetings and orchestrate executive decision‑making to guarantee project success aligned with Business Development and PMO criteria.
• Leverage industry experience to lead team closure of deviations, CAPAs, change controls, and investigations in advance of QA assigned deadlines.
• Prepare media, buffers, single‑use assemblies, and components as required.
• Execute cell expansion of seeds and viral seeds as required.
• Expand microbial and mammalian cells from vial thaw to shake flasks, passage into fermenters/bioreactors and harvest, filter or lyse as required.
• 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.
• Analyze UNICORN and other downstream result files, attach per GDP to records, summarize data, and incorporate analysis into run reports as required.
• Annually qualify as additional fill‑finish support, supporting the fill‑finish team in preparation, execution and changeover of drug product processes.
• Implement, operate, maintain and train on equipment in multiple operations areas or as assigned by area managers.
• Spot‑clean GMP manufacturing areas, leverage the aseptic technique, and use grade‑appropriate personal protective equipment as required to maintain GMP spaces within environmental monitoring compliance specifications.
• Actively promote and enforce Quality Assurance compliance and good documentation practices for manufacturing documents, procedures, and records per relevant SOPs.
• Process on‑floor offline sampling using cGMP analytical equipment and materials.
• Follow sample‑chain‑of‑custody, sample, transfer, disposition and shipping SOPs as required.
• Respond to alarms, manage and maintain manufacturing‑owned controlled temperature units (CTUs) and incubators per site policies and procedures.
• Maintain unconditional compliance with Good Documentation Practices (GDP) and ALCOA+ principles across all upstream and downstream GMP operations; accurately execute real‑time batch record logging, logbook entries, and electronic management of critical manufacturing records.
• Safeguard Controlled Unclassified Information (CUI) and proprietary process data, ensuring zero data integrity breaches during high‑stakes commercial production runs.
• Maintain a safe workplace by following all applicable safety and occupational health policies and procedures. Employees must complete job‑related safety training and report any safety violations to the facility Safety Officer.
• Perform light duties and other related duties as required and assigned, including working in other sections.