Senior Engineer I, External MSAT

Role: Senior MSAT Manufacturing Technical Expert supporting external GMP manufacturing of mRNA, lipids, small molecules, VHH antibodies, and plasmids. Responsibilities: facilitate seamless technology transfer into CMOs, author and review GMP documentation, lead change controls, review deviations and investigations, oversee validation activities, and drive data review and process verification. Collaborate closely with internal Quality, Manufacturing, and Supply Chain teams, and external CMO partners to ensure compliance, quality, and continuous improvement. Ensure adherence to GxP standards, data integrity, and inspection readiness. Qualifications: B.S., M.S., or Ph.D. in Pharmaceutical Engineering, Chemistry, or Biochemistry with 4-10 years in pharma/biotech manufacturing, GMP experience, knowledge of data analysis tools, excellent communication, and cross-functional collaboration skills. Preferred: CMO experience, experience with biologics and cell/gene modalities, and expertise in digital data platforms. High-Value: GMP manufacturing, technology transfer, biologics and mRNA modalities, lifecycle management, validation oversight, data analytics, global cross-functional collaboration. Work Setup: hybrid in Norwood, MA, with a focus on innovation, data-driven continuous improvement, and compliance in a fast-paced biopharma environment.