Science Jobs

Sr. Engineer, Drug Product & Substance Manufacturing

Therapeutics Development / Engineering
  • Job ID: 19298
  • Direct Hire
  • MA
Email

Our Vaccine client is growing and looking to add an Engineer/Sr. Engineer, Drug Product & Substance Manufacturing (can hire remote w/travel) to their team!  Role will support late stage drug substance and drug product development and manufacturing activities performed at the Contract Manufacturing sites.  This position will have responsibility of supporting compliance by performing process validation activities and  documenting deviation investigations, change controls supporting oversight of clinical manufacturing of drug substance and drug product.  This individual will work with a cross functional team across Tech Ops, Quality, MSAT, Supply Chain, and Analytical Development teams to support investigations and prepare required documentation, for clinical manufacturing, validation and PPQ.
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 Quality and cGMP documentation to support clinical trials.

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

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

  • Partner with Quality in development of documentation required to support process validation (stage 2 & 3) and cGMP manufacturing for intermediates, drug substance, sterile drug products and analytical testing.

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

  • Prepare and review CMC sections of regulatory filings and interfacing with the regulatory agencies.

  • Provide technical assessments 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 Tech Ops, Quality, Analytical Development, Project Management, Clinical Operations, Finance and Regulatory Affairs.

Requirements:

  • BS / MS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 5+ years in the sterile vaccine manufacturing environment (Ph.D. with minimum of 3 years).

  • Experience / understanding of technical aspects of biotechnology unit operations from bioreactors, purification, formulation, sterile drug product manufacturing, analytical testing and Quality release.

  • Direct experience in GMP manufacturing, and interfacing with both Quality and Regulatory affairs.

  • Experienced in preparing cGMP documentation (deviations, change controls, protocols, reports) and interfacing with key partners for approval and/or implementation.

  • Proficiency in statistical software for data analysis and tracking and trending.