Bioprocess Specialist

CAMRIS; Silver Spring (MD); On-site; USD 80,000 - 110,000; Full time

Job summary

CAMRIS International is seeking a Bioprocess Specialist to support the Pilot Bioproduction Facility at WRAIR in Silver Spring, MD. The role focuses on SOPs, batch records, and cGMP operations across upstream/downstream activities.

You will collaborate with QA, QC, Engineering, and Materials teams to ensure compliant manufacturing and timely documentation, while supporting training and aseptic processing as needed.

Qualifications

• Experience in cGMP manufacturing environments.
• Ability to prepare media, buffers, and single-use assemblies.
• Proficient in documenting and reviewing batch records and QA documentation.
• Strong communication with QA, QC, Engineering, and production teams.

Responsibilities

• Author, revise, and maintain SOPs, batch records, and work instructions.
• Operate and support cGMP equipment qualification activities.
• Execute manufacturing operations per cGMP, GDP, and SOPs.
• Document deviations and issues per site procedures.
• Maintain clean, compliant manufacturing spaces and PPE practices.
• Collaborate with multiple PBF functions to align on schedules and priorities.
• Prepare media, buffers, and components for operations.
• Perform on-floor sampling with cGMP analytical tools.
• Generate run reports and quality documentation per policies.
• Support aseptic manufacturing and fill/finish activities when assigned.
• Train personnel in approved procedures and equipment operation.
• Ensure timely entry of data into product and operation records.

Skills

cGMP knowledge

Good Documentation Practices

SOP development

Data entry accuracy

Cross-functional communication

Tools

UNICORN software

Job description

Overview

We are seeking a 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 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.

Responsibilities

• Author, revise, and maintain standard operating procedures (SOPs), batch records, work instructions, and other controlled manufacturing documentation.
• Implement, operate, maintain, clean, and support qualification activities for cGMP equipment, as assigned by the area manager.
• Execute manufacturing operations in compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), approved SOPs, batch records, and Quality Assurance requirements.
• Review, complete, and contemporaneously document manufacturing records, procedures, logbooks, forms, and associated quality documentation. Identify and promptly elevate deviations, equipment concerns, documentation discrepancies, and process issues in accordance with site procedures.
• Maintain cGMP manufacturing spaces through appropriate cleaning, aseptic technique, and grade-appropriate personal protective equipment (PPE) practices, consistent with environmental-monitoring and contamination-control requirements.
• Communicate effectively and consistently with Manufacturing, Quality Assurance, Quality Control, Engineering, Supply Chain, and other PBF functional teams.
• Manage cGMP project inventory and Kanban inventory in accordance with site policies and procedures.
• Prepare media, buffers, single-use assemblies, consumables, and components required for manufacturing operations.
• Perform on-floor, offline sampling using cGMP analytical equipment and materials, as required.
• Generate manufacturing deep-dives, process summaries, run reports, and quality documentation in accordance with site policies and procedures.
• Execute cell expansion activities for seed cultures and viral seeds, as required.
• Manage and maintain manufacturing-owned controlled-temperature units (CTUs) and incubators in accordance with site policies and procedures.
• Perform bioreactor setup, operation, monitoring, maintenance, cleaning, and associated documentation activities.
• Prepare harvest equipment in accordance with SOPs, batch records, and site procedures.
• Execute cell lysis using chemical or physical cell-disruption methods, including microfluidization, as required.
• Perform recovery and midstream unit operations, including depth filtration, centrifugation, and tangential flow filtration (TFF), in accordance with approved procedures.
• Pour resin, pack chromatography columns, verify height equivalent to a theoretical plate (HETP) and asymmetry, equilibrate columns, and sanitize, empty, and store columns in accordance with site procedures.
• Develop and execute purification batch records and UNICORN methods, as assigned.
• Analyze UNICORN and other downstream-process data files; attach records in accordance with GDP requirements; summarize data; and incorporate results into manufacturing run reports.
• Support aseptic manufacturing and fill/finish activities, when assigned, including preparation, setup, execution, cleaning, documentation, and related manufacturing support.
• Train other personnel in approved procedures, equipment operation, and manufacturing activities, as assigned.
• Ensure complete, accurate, and timely entry of data into records maintained for each product and manufacturing operation.
• Maintain a safe workplace by observing applicable safety, occupational health, biosafety, and environmental requirements. Attend required safety training and report safety concerns or procedural infractions to the appropriate facility representative.
• Provide cross-functional support across PBF manufacturing and operational areas, including upstream processing, downstream processing, formulation, fill/finish, equipment preparation, materials management, and associated support functions, based on production schedules, operational demands, and evolving program priorities.
• Perform