Job description
Title: Associate Scientist
Location: Devens, MA
Start date: ASAP
Responsibilities:
- The Associate Scientist in Manufacturing Sciences & Technology will support the Materials Science group in the life cycle management of raw materials, consumables and single-use systems utilized for biopharmaceuticals commercial manufacturing operations. The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement groups on cross-functional teams.
- The subject matter expert for this position will be primarily required to:
- Provide technical expertise for material qualification and implementation including authorship of material risk assessments, technical assessments and reports
- Support material specification development
- Perform impact assessments and author change controls on material-related supplier change notifications to maintain GMP compliance.
- Recommend and/or lead necessary testing to qualify material for use in GMP manufacturing
- Support material and consumable manufacturing investigations
Requirements:
- B.S. in Chemical, Biochemical, Material Science Engineering, Physics or Chemistry
- Awareness of cGMP compliance and regulatory agency requirements.
- Demonstrated problem solving ability
- Strong oral communication and technical writing skills
- Laboratory experience
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