MSAT Engineer

Job Description

We are seeking an MSAT mRNA/DNA Scientist 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.

• 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 lipid nanoparticle (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.

• 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 nanoparticle 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.)…