Job Details
Posted 18 June, 2026
Job Id: 628448
Materials Specialist
Job Description
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.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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