Sr. Upstream Process Engineer, Drug Substance

Our clinical stage pharmaceutical client here in Boston, MA is growing and looking to add a Sr. Upstream Process Engineer, Drug Substance to their team (Hybrid 2-3 days onsite/WFH)! This role will support late-stage drug substance manufacturing activities performed at the Contract Manufacturing sites to support company's programs. Sr. PE will have responsibility for providing scientific/technical thought and contribution for author / review of documentation for clinical manufacturing, late-stage process validation and commercialization of drug substance at Contract Manufacturing Organizations (CMOs). Role will work with a cross functional team across Tech Ops, including CMC Development, MSAT, Supply Chain, and Analytical Development teams to identify gaps and add manufacturing robustness for preparation of engineering lots, and GMP lots through PPQs. Responsibilities include but not limited to:

• Contribute scientific and technical aspects to assist managing relationships with CMOs, CROs and key suppliers. This will include coordination, communication, and technical understanding to assist timely delivery of cGMP products to support 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 development of documentation required to support validation and cGMP manufacturing for sterile products.

• Collaborate with Regulatory Affairs partners ensuring Health Authority requirements are satisfied.

• 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 interfacing with the regulatory agencies.

• Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to 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.

Requirements:

• 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.

Other:

• Strong preference for Boston local candidates to be on-site 2-3 days per week.

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required (Up to 30%).