Target PR Range:
61-71/hr DOE Summary
- The Scientist, Materials Science supports onboarding, qualification and life-cycle management of single-use materials used in the early
- and late
- stage AAV Drug Substance and Drug Product manufacturing.
In this role, you will report to the Director of Material Science in MSAT. This position requires strong technical writing, attention to detail, and the ability to effectively collaborate across multiple functions in a fast-paced manufacturing environment.
Responsibilities :
1. Support onboarding and qualification of single-use manufacturing components, including bags, tubing, filters, connectors, and assemblies. 2. Perform material assessments and extractables/leachables (E&L) risk assessments using established SOPs, templates, and risk assessment tools. 3. Review supplier documentation, material certifications, extractables reports, and technical packages to support material qualification. 4. Develop and document testing recommendations and requirements for material qualification activities. 5. Coordinate testing activities with external laboratories and suppliers and track study progress. 6. Review analytical reports and summarize results for technical assessments and qualification packages. 7. Support material-related change controls, investigations, and impact assessments. 8. Author and maintain technical documents, risk assessments, reports, and qualification records in accordance with GMP documentation practices. 9. Collaborate with MSAT, Process Development, Manufacturing, Quality Control, and Quality Assurance teams to support material onboarding and lifecycle management activities. 10. Maintain project timelines and communicate progress to stakeholders.
Requirements:
1. B.S. or M.S. in Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related scientific discipline. 2. 3-6 years of experience in biotechnology, pharmaceutical, medical device, or related regulated industries. 3. Experience with single-use systems, manufacturing materials, or extractables and leachables (E&L) assessments.
