Materials Specialist

A biotechnology organization is seeking a Materials Specialist to support the onboarding, qualification, and lifecycle management of single-use materials used in AAV drug substance and drug product manufacturing. This role focuses on technical assessment, documentation, and cross-functional collaboration within a regulated manufacturing environment.

About the Opportunity:

• Shift: Day shift
• Hours: Standard business
• Setting: Hybrid

Responsibilities:

• Support onboarding and qualification of single-use manufacturing components, including bags, tubing, filters, connectors, and assemblies.
• Perform material assessments and extractables/leachables risk assessments using established SOPs, templates, and risk assessment tools.
• Review supplier documentation, material certifications, extractables reports, and technical packages to support material qualification.
• Develop and document testing recommendations and requirements for material qualification activities.
• Coordinate testing activities with external laboratories and suppliers, track study progress, and summarize analytical results for technical assessments.

Qualifications:

• 3-6 years of experience in biotechnology, pharmaceutical, medical device, or another regulated industry
• B.S. or M.S. in Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related scientific discipline
• Experience with single-use systems, manufacturing materials, or extractables and leachables assessments
• Strong technical writing skills and attention to detail

Desired Skills:

• Experience supporting material-related change controls, investigations, and impact assessments
• Familiarity with GMP documentation practices and qualification records
• Exposure to cross-functional collaboration with MSAT, Process Development, Manufacturing, Quality Control, and Quality Assurance teams