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
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Support All-stream operations activity, teaching others core department functions while contributing to at least three other operations areas.
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Configures, observes, reports and responds to process values as a clinical manufacturing operator (considered R&D).
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Initiates and authors deviations for out-of-specification results.
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Advises other SMEs and clients in the areas of specialized processes, aseptic technique, cell banking, TFF, and general bioprocess equipment technology, maintenance and operation.
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Author and review standard operating procedures and record revisions.
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Coordinate with and support manufacturing sciences and technology process characterization and development activities as required supporting advancement of phase 1 clinical manufacturing.
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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.
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Lead high-visibility project meetings and orchestrate executive decision-making to guarantee project success aligned with Business Development and PMO criteria.
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Leverage industry experience to lead team closure of deviations, CAPAs, change controls, and investigations in advance of QA assigned deadlines.
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Prepare media, buffers, single-use assemblies, and components as required.
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Execute cell expansion of seeds and viral seeds as required.
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Expand microbial and mammalian cells from vial thaw to shake flasks, passage into fermenters/bioreactors and harvest, filter or lyse as required.
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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.
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Analyze UNICORN and other downstream result files, attach per GDP to records, summarize data, and incorporate analysis into run reports as required.
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Annually qualify as additional fill-finish support, supporting the fill-finish team in preparation, execution and changeover of drug product processes.
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Implement, operate, maintain and train on equipment in multiple operations areas or as assigned by area managers.
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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.
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Actively promote and enforce Quality Assurance compliance and good documentation practices for manufacturing documents, procedures, and records per relevant SOPs.
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Process on-floor offline sampling using cGMP analytical equipment and materials.
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Follow sample-chain-of-custody, sample, transfer, disposition and shipping SOPs as required.
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Respond to alarms, manage and maintain manufacturing-owned controlled temperature units (CTUs) and incubators per site policies and procedures.
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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.
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Safeguard Controlled Unclassified Information (CUI) and proprietary process data, ensuring zero data integrity breaches during high-stakes commercial production runs.
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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.
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Perform light duties and other related duties as required and assigned, including working in other sections.
Qualifications
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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 trials.
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Extensive experience in the operation of cell disruption equipment, centrifuges, chromatography systems, and ultrafiltration.
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Experience with at least one of the following (aseptic technique, bioreactor operation, BioCommand® SCADA Software, KrosFlo® KMPi Tangential Flow Filtration (TFF) Systems, AKTA UNICORN method development, column packing, and single-use systems.
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Experience with supportive equipment, such as validated washers, depyrogenation ovens, and autoclaves, is preferred.
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mRNA IVT or LNP experience is preferred.
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Fill-finish and lyophilization experience is preferred.
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Strong interpersonal and communication skills (written and verbal).
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Must be currently eligible to work in the United States without visa sponsorship and have lived in the United States for three of the past five years if a non-US citizen.
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A REAL ID or a U.S. passport is required to get on base at WRAIR.
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
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Constantly conduct sedentary work that primarily involves sitting/standing.
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Constantly conduct light work that includes moving objects up to 20 pounds.
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Occasionally conduct medium work that includes moving objects up to 50 pounds.
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Occasionally conduct heavy work that includes moving objects up to 100 pounds.
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Constantly push or pull less than 25 pounds.
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Occasionally push or pull 25 -45 pounds.
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Occasionally push or pull more than 45 pounds.
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Occasionally reach above shoulder level.
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Constantly use both hands.
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Constantly stand or walk for more than 25 minutes.
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Occasionally bend, reach, or twist repeatedly.
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Occasionally kneel, squat, or stoop.
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Occasionally crawl or climb.
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Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.
Physical Activities
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Occasionally ascend of descend ladders, stairs, scaffolding, ramps, poles, and the like.
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Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces.
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Constantly move about to accomplish tasks or move from one worksite to another.
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Constantly communicate with others to exchange information.
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Constantly operate machinery and/or power tools.
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Constantly assess the accuracy, neatness, and thoroughness of the work assigned.
Environmental Conditions
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Occasionally work in noisy environments.
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Occasionally work in hazardous conditions.
PPE and Chemical Requirements
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Constantly wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
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Constantly wear a lab coat.
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Occasionally wear earplugs/muffs.
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Constantly wear a clean room uniform.
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Occasionally wear a disposable dust/surgical mask.
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Occasionally 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.
