The Senior Engineer II in Material Science, within Manufacturing Sciences and Technology (MSAT), is responsible for supporting MSAT material science activities for tech transfer, process validation, and routine GMP manufacturing. He/She serves as the subject matter expert for single-use technologies (SUT) and raw materials (RM) with in-depth knowledge of industry best practices and regulatory guidelines.

The candidate will support resolving complex problems and drive SUT and RM process standardization, strategy sourcing, and control strategy in collaboration with cross-functional teams to bring the best practices in SUT and RM to enhance the reliability and consistency of viral vector production for internal and external contract manufacturing facilities.

Work Model:

Core Lab & Ops: This role is in the Gene Therapy Manufacturing Facility typically requires that the majority of the work be conducted on-site.

Responsibilities

• Lead external lab studies for extractable and leachable along with the risk assessments
• Lead the Assessment of new materials, and implement best practices in SUT and RM across multiple programs, including a phase-appropriate program and control strategy based on scientific and risk principles
• Compile vendor source documents and author technical and risk assessment documents to support SUT and RM onboarding, including authoring functional risk assessments and component design reviews for SUT, and technical assessments for alternative new and alternative chemical assessments
• Support identification and control of material attributes for GMP operation of drug substances, drug products and ancillary devices.
• Support supplier notification/deviation/investigation and change controls as a material SME in a fast-paced GMP facility
• Support QC raw material risk assessment and help to identify material to be used for testing as needed
• Be familiar with container closure integrity (CCIT) and support CCIT testing for drug substance and drug product
• Partner with Manufacturing, Supply Chain, and Quality teams to address material improvements and alternate sourcing opportunities
• Author technical documents and regulatory submissions

Requirements

• S/M.S in Material Science, Chemical Engineering, or Polymer Science. B.S with 5 - 7+ or MS with 4 - 6+ yrs of relevant experience working in Pharmaceutical Manufacturing environment
• Strong knowledge in extractable and leachable, single-use and raw material risk assessment
• ≥ 3 years direct experience in SUT, filters, chromatography resins, excipients, and primary packaging and/or secondary packaging. Including prior experience working on consumable and single-use assessments
• Solid understanding of cGMP compliance and regulatory agency requirements for raw materials and SUT.
• Solid knowledge of chemical raw material standards (USP, compendia, BPOG, etc.)
• Strong understanding of polymers and chemicals, their function in bioprocesses, and their impact on cells and viral vectors.
• Demonstrated problem-solving ability in a fast-paced environment.
• Strong communication and technical writing skills
• Strong collaboration and team-building, communication, and organizational skills required
• Experience working with and managing third-party contractors and vendors is a plus
• Experience owning, managing, and executing records using a quality management system (Veeva) is a plus
• Travel Requirements 10% estimate #LI-CS1 #LI-Onsite