HireMinds · 3 days ago

Sr. Upstream Process Engineer, Drug Substance

Greater Boston

Full-time

Hybrid

Senior Level

6+ years exp

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Responsibilities

Contribute scientific and technical aspects to assist managing relationships with CMOs, CROs, and key suppliers. This includes coordination, communication, and technical understanding to ensure timely delivery of cGMP products for clinical trials.

Support the creation, development, and review of gap assessments, late-stage product development, and industrialization.

Work closely with CDMOs to support and manage GMP batch manufacture and testing, support deviation investigations, batch review, and release of GMP material.

Assist in the review of Manufacturing Batch records and sampling plans in collaboration with the CDMO teams.

Partner with Quality in the development of documentation required to support validation and cGMP manufacturing for sterile products.

Collaborate with Regulatory Affairs partners to ensure Health Authority requirements are met.

Partner with MSAT to drive vaccine technology transfer and scale-up of process improvements as required at the CMOs.

Prepare and review CMC sections of regulatory filings and interface with regulatory agencies.

Provide technical recommendations for evaluating process data, troubleshooting, root cause analysis, and strategic recommendations for improved yields, cost of goods, and process robustness.

Travel as required to CMO and key vendors for Manufacturing oversight and partnership for commercialization purposes.

Partner with key functions including Quality, Project Management, Clinical Operations, Finance, and Regulatory Affairs.

Qualification

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Tech TransferGMP PracticesStatistical Software ProficiencyBoston Local CandidatesMeetings PreferenceWillingness to Travel

Required

BS / MS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 6-10 years in the GMP manufacturing environment (Ph.D. with minimum of 5 years).

Experience / understanding of technical areas related to processes, unit operations and functions involved in drug substance manufacturing (e.g. Cell Expansion, Viral production, Yeast fermentation, SU Bioreactors, Harvest and Clarification)

Direct experience in tech transfer and GMP manufacturing activities at the CDMOs

Knowledge of cGMP practices as applicable to technology transfer, manufacturing, drug substance, and analytical development

Proficiency in statistical software for data analysis and tracking and trending