MSAT Engineer

Overview

Job Description

We are seeking a

MSAT Engineer

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

• Coordinate with PMO as Technology Transfer Lead on multiple CDMO projects, conducting regular project meetings and driving project execution, scheduling, monitoring of budgets, technical decision making, and project deliverables.
• Design and execute process development studies to support Upstream (culture through harvest), Downstream (harvest/clarification, purification) and/or mRNA production (inclusive of in-vitro transcription (IVT) and/or LNP encapsulation) to support GMP Manufacturing.
• Develop experimental plans and batch records and execute and/or direct the team in the execution of studies.
• Troubleshoot process issues and support QA technical investigations as required.
• Interpret and summarize publications, donor process information, and experimental data.
• Develop scale-up processes and cost-benefit analyses for Upstream and/or Downstream operations.
• Train and mentor development and operations staff in Upstream and/or Downstream functions.
• Develop data summaries and present to clients in team meetings.
• Author, review, and execute technology transfer plans, gap assessments, process descriptions, and standard operating procedures.
• Author relevant sections of regulatory filings, such as INDs and IMPDs, as needed.
• Leverage quality by design (QbD) principles and technical risk assessments.
• Support the review and approval of transfer and manufacturing documentation, such as batch records, standard operating procedures, protocols, and summary reports.
• Make recommendations based on study results, scientific principles, and industry best practices on clone selection and process design.
• Supervise, train, and mentor peers as needed and delegate/plan work within the team, as well as work hands-on with the team in the laboratory.
• Support and coordinate with other MSAT technical staff (mRNA, Cell Culture, viral etc.).
• Perform GMP operations and other tasks as required.

Qualifications

• A master's degree in a science field (preferably chemistry, biochemistry, microbiology, or engineering) and 6 years of experience in a regulated environment, or an equivalent combination of education and credentials.
• Knowledge and experience in Upstream development and scale-up (microbial or cell culture, inclusive of media selection, seed train development, and development/optimization of expression in production cultures or mRNA In-Vitro Transcription development/optimization and lipid encapsulation), process optimization, scale-up, scale-down, and technology transfer.
• Knowledge and experience of Downstream development and scale-up (chromatography inclusive of media and buffer selection and optimization, tangential flow filtration, and viral filtration), process optimization, scale-up, scale-down, and technology transfer.
• Knowledge of analytical methods needed to support characterization and testing of associated biologics (protein, mRNA, etc.) is a plus.
• Ability to utilize development and process experience over multiple process platforms.
• High throughput process development (HTPD) experience (preferred).
• Working knowledge of DOE, including software such as R, SAS, and JMP.
• Excellent initiative, troubleshooting, and problem-solving skills.
• Strong communication (written and verbal), organizational, and time management skills.
• Ability to work well independently and as part of a team.
• Must have eligibility to work in the United States and have lived in the United States for three of the past five years if a non-US citizen.

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.
• Occasionally conduct light work that includes moving objects up to 20 pounds. Rarely conduct medium or heavy work that includes moving objects up to 100 pounds.
• Occasionally push or pull less than 25 pounds, push or pull 25 - 45 pounds, rarely push or pull more than 45 pounds.
• Rarely reach above shoulder level.
• Constantly use both hands.
• Occasionally stand or walk for more than 25 minutes.
• Rarely bend, reach, or twist repeatedly.
• Rarely kneel, squat, or stoop.
• Rarely crawl or climb.
• Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

Physical Activities

• Rarely ascend or 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.
• Rarely operate machinery and/or power tools.
• Constantly assess the accuracy, neatness, and thoroughness of the work assigned.

Environmental Conditions

• Rarely work in low temperatures.
• Rarely work in outdoor elements, such as precipitation and wind.
• Rarely work in noisy environments.
• Rarely work in hazardous conditions.
• Rarely work in poor ventilation.
• Rarely work in small and/or enclosed spaces.
• Rarely work in environments where no adverse environmental conditions are expected.

PPE and Chemical Requirements

• Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
• Constantly wear a lab coat.
• Rarely wear ear plugs/muffs.
• Occasional work in a Clean Room Uniform.
• Occasionally wear a disposable dust/surgical mask.
• Rarely wear respirators, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.
• Rarely 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.