Manufacturing Process Scientist, Drug Product Manufacturing (Temp to Perm)

Our Vaccine client here in Boston, MA is looking to hire a Manufacturing Process Scientist in their Drug Product Manufacturing group (Temp to Perm).  Role will support late-stage drug product development in laboratories located in Boston and manufacturing activities performed at the Contract Manufacturing sites.  This position will have responsibility for providing scientific thought and contribution for authoring / review of documentation for late-stage process development activities, validation and clinical manufacturing of drug product at a Contract Manufacturing Organization (CMO).  This individual 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 through validation and PPQ.  We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late-stage clinical development.

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.

Requirements:

  • BS / MS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 5-7 years in the sterile vaccine manufacturing environment (Ph.D. with minimum of 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. aseptic 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.
  • 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.

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. 
  • Up to 5-10%.