MSAT mRNA/DNA Scientist

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 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.
• 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 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.) 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.