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
The Bioprocess Specialist will perform hands-on cGMP manufacturing and operational support activities in accordance with approved procedures, batch records, quality-system requirements, and site policies. Responsibilities include:
- 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 escalate 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 other related duties as assigned.
Required Qualifications
- 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 within a pharmaceutical, biotechnology, biologics, vaccine, or similarly regulated production environment.
- Demonstrated experience following approved SOPs and batch records; applying GDP; performing contemporaneous documentation; executing manufacturing operations; and escalating deviations, equipment issues, and process concerns in accordance with quality-system requirements.
- Professional knowledge of the 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.
- Must be able 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.
Preferred Qualifications
- Hands-on experience supporting aseptic fill/finish operations in a cGMP environment, including equipment preparation, setup, manufacturing execution, documentation, cleaning, and line clearance activities.
- Experience with lyophilization operations.
- Experience supporting monoclonal antibody (mAb) manufacturing, including upstream processing, downstream purification, formulation, aseptic fill/finish, process characterization, technology transfer, or associated manufacturing-support activities.
- Experience with supportive manufacturing equipment, such as validated washers, depyrogenation ovens, and autoclaves.
Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements
The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.
Physical Demands
- Constantly conduct sedentary work that primarily involves sitting/standing.
- Constantly conduct light work that includes moving objects up to 20 pounds.
- Occasionally conduct medium work that includes moving objects up to 50 pounds.
- Occasionally conduct heavy work that includes moving objects up to 100 pounds.
- Constantly push or pull less than 25 pounds.
- Occasionally push or pull 25 -45 pounds.
- Occasionally push or pull more than 45 pounds.
- Occasionally reach above shoulder level.
- Constantly use both hands.
- Constantly stand or walk for more than 25 minutes.
- Occasionally bend, reach, or twist repeatedly.
- Rarely kneel, squat, or stoop.
- Rarely crawl or climb.
- Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.
Physical Activities
- Rarely ascend of descend ladders, stairs, scaffolding, ramps, poles, and the like.
- Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces.
- Constantly move about to accomplish tasks or move from one worksite to another.
- Constantly communicate with others to exchange information.
- Constantly operate machinery and/or power tools.
- Constantly assess the accuracy, neatness, and thoroughness of the work assigned.
Environmental Conditions
- Occasionally work in noisy environments.
- Occasionally work in hazardous conditions.
- Rarely work in poorly ventilated areas.
- Rarely work in small and/or enclosed spaces.
PPE and Chemical Requirements
- Constantly wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
- Constantly wear a lab coat.
- Occasionally wear earplugs/muffs.
- Constantly wear a clean room uniform.
- Occasionally wear a disposable dust/surgical mask.
- Constantly come in contact with chemicals, such as aerosols, biological inhalants, plastics, inorganic dust and powders, etc.
Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.
Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.