Manufacturing Process Scientist, Drug Product Manufacturing

Boston, MA

Our client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will author/review documentation for late-stage process development activities and work cross-collaboratively to identify gaps and add manufacturing robustness for the preparation of engineering lots through validation and PPQ.

*This is a full-time, temporary contract role with the possibility of converting to a permanent position after about 3-4 months.

Responsibilities:

• 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.
• Contribute to experimental designs and execution to improve process/product knowledge for increased process robustness and product stability.
• 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 industrialization purposes.
• Partner with key functions including Quality, Project Management, Clinical Operations, Finance and Regulatory Affairs.

Education, Experience & Skills:

• BS / MS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a preferably 5-7 years in the sterile vaccine manufacturing environment (Ph.D. with preferably 2 years).
• Experience/understanding of technical areas related to processes, unit operations and functions involved in sterile vaccine drug product development and manufacturing (e.g. aspetic media simulations)
• Technical experience with prefilled syringes and sterile injectables.
• Direct experience in process development and GMP manufacturing activities at the CDMOs.
• Demonstrated ability to work effectively in a team-oriented CMC environment.
• Excellent communication skills, both written and oral.
• Knowledge of cGMP practices as applicable to technology transfer, manufacturing, drug product formulation, and analytical development.
• Proficiency in statistical software for data analysis and tracking and trending.
• Proven experience in a matrix environment is preferred.
• Demonstrated ability to work efficiently across multiple project teams and business functions.

Travel Requirements:

• 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 (5-10%).