Bioprocess Specialist

CAMRIS•Silver Spring, MD

7d•Onsite

About The Position

The Bioprocess Specialist supports the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a cGMP-compliant pharmaceutical manufacturing facility that supports development and manufacturing projects for companies and government agencies. The role performs hands-on cGMP manufacturing and operational support in accordance with approved procedures, batch records, quality-system requirements, and site policies. It also provides cross-functional support across upstream and downstream processing, formulation, fill/finish, equipment preparation, materials management, and related operational areas, based on production schedules and program priorities. The position includes preparing and executing manufacturing documentation and operations; operating, maintaining, cleaning, and supporting qualification of equipment; preparing materials; performing cell culture, bioreactor, cell-disruption, recovery, filtration, and chromatography activities; and supporting aseptic manufacturing and fill/finish when assigned. The specialist analyzes and documents process data, maintains inventory and controlled-temperature equipment, trains personnel as assigned, and follows applicable safety, occupational health, biosafety, and environmental requirements. The role requires a bachelor's degree in a relevant science or engineering discipline and at least four years of relevant experience, or an equivalent combination of education, credentials, and experience. Candidates must be eligible to work in the United States without visa sponsorship, be able to complete and maintain a Tier 1 investigation clearance, and be able to obtain WRAIR base access. A REAL ID-compliant identification card or U.S. passport is required. Non-U.S. citizens must have resided in the United States for at least three of the past five years. Employment is contingent upon successful completion of a Public Trust-level background check.

Requirements

Bachelor's degree in science, preferably chemistry, biochemistry, biology, microbiology, engineering, or a related discipline, and at least four years of relevant experience in a regulated laboratory or manufacturing environment; or an equivalent combination of education, credentials, and experience.
Demonstrated hands-on experience performing GMP or cGMP manufacturing operations in a pharmaceutical, biotechnology, biologics, vaccine, or similarly regulated production environment.
Experience following approved SOPs and batch records; applying GDP; performing contemporaneous documentation; executing manufacturing operations; and escalating deviations, equipment issues, and process concerns under quality-system requirements.
Professional knowledge of principles and practices applicable to purification and downstream processing of biologics, vaccines, or related materials intended for early-phase clinical trials.
Extensive experience operating cell-disruption equipment, centrifuges, chromatography systems, and ultrafiltration or tangential flow filtration systems.
Hands-on experience with one or more of the following: aseptic technique; bioreactor operation; BioCommand SCADA software; KrosFlo KMPi TFF systems; UNICORN method development; column packing; and single-use systems.
Ability and willingness to support multiple manufacturing areas as operational demands, production schedules, and program priorities evolve.
Strong interpersonal, written, and verbal communication skills.
Eligibility to work in the United States without visa sponsorship; non-U.S. citizens must have resided in the United States for at least three of the past five years.
Ability to successfully complete and maintain a Tier 1 investigation clearance.
Ability to obtain base access at WRAIR; a REAL ID-compliant identification card or U.S. passport is required.
Ability to meet the described physical requirements, including moving objects up to 100 pounds occasionally, standing or walking for extended periods, operating machinery and power tools, and wearing required PPE and clean-room clothing.
Successful completion of a Public Trust-level background check is required for employment.

Nice To Haves

Hands-on experience supporting cGMP aseptic fill/finish operations, including equipment preparation, setup, manufacturing execution, documentation, cleaning, and line clearance.
Experience with lyophilization operations.
Experience supporting monoclonal antibody manufacturing, including upstream processing, downstream purification, formulation, aseptic fill/finish, process characterization, technology transfer, or related manufacturing support.
Experience with supportive manufacturing equipment such as validated washers, depyrogenation ovens, and autoclaves.

Responsibilities

Author, revise, and maintain SOPs, batch records, work instructions, and other controlled manufacturing documentation.
Implement, operate, maintain, clean, and support qualification activities for cGMP equipment as assigned.
Execute manufacturing operations in compliance with cGMP, GDP, approved procedures, batch records, and Quality Assurance requirements.
Review, complete, and contemporaneously document manufacturing records, procedures, logbooks, forms, and quality documentation; promptly escalate deviations, equipment concerns, documentation discrepancies, and process issues.
Maintain cGMP manufacturing spaces through appropriate cleaning, aseptic technique, and grade-appropriate PPE practices consistent with environmental-monitoring and contamination-control requirements.
Communicate with Manufacturing, Quality Assurance, Quality Control, Engineering, Supply Chain, and other PBF teams.
Manage cGMP project inventory and Kanban inventory according to site policies and procedures.
Prepare media, buffers, single-use assemblies, consumables, and components 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.
Execute cell expansion activities for seed cultures and viral seeds as required.
Manage and maintain manufacturing-owned controlled-temperature units and incubators.
Perform bioreactor setup, operation, monitoring, maintenance, cleaning, and related documentation.
Prepare harvest equipment in accordance with SOPs, batch records, and site procedures.
Execute chemical or physical cell lysis, including microfluidization, as required.
Perform recovery and midstream operations, including depth filtration, centrifugation, and tangential flow filtration.
Pour resin, pack chromatography columns, verify HETP and asymmetry, equilibrate columns, and sanitize, empty, and store columns.
Develop and execute purification batch records and UNICORN methods as assigned.
Analyze UNICORN and other downstream-process data files; attach records according to 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 support.
Train other personnel in approved procedures, equipment operation, and manufacturing activities as assigned.
Ensure complete, accurate, and timely data entry for each product and manufacturing operation.
Maintain a safe workplace by observing safety, occupational health, biosafety, and environmental requirements; attend required safety training and report concerns or procedural infractions.
Provide cross-functional support across PBF manufacturing and operational areas based on production schedules, operational demands, and evolving program priorities.
Perform other related duties as assigned.