Associate Scientist - MSAT (Biologics Manufacturing, Materials, Polymers)
About The Position
The Associate Scientist in Manufacturing Sciences & Technology will support the Materials and Cryogenics Science group in the run the business work for cryogenics, consumables and single-use systems 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: Support material and cryogenics technical evaluations, risk assessment and change management activities; Executes material control strategies, validations and qualifications, as appropriate, including life-cycle management. Evaluate and manage material associated supplier changes notifications to maintain GMP compliance. Support cryogenics and cold-chain transportation related lab studies or activities. Assist material and cryogenics manufacturing investigations. Author and revise CMC documents as appropriate. Author protocols, reports, and technical presentations. Position Handles Hazardous Materials
Requirements
- Minimum B.S. with 2+ years of industry experience; or M.S. in Chemical Engineering, Biochemical Engineering, Material Science Engineering, Chemistry or equivalent scientific background.
- Required knowledge of common protein analytical tools and demonstrated experimental skills for lab work.
- Awareness of cGMP compliance and regulatory agency requirements.
- Knowledge of Material science and polymers.
- Strong organizational, oral communication and technical writing skills.
- Strong attention to details, excellent experimental/troubleshooting aptitude, and be self-motivated.
- Effective team player and strong individual contributor.
Nice To Haves
- Knowledge of manufacturing process validation is a plus.
Responsibilities
- Support material and cryogenics technical evaluations, risk assessment and change management activities
- Executes material control strategies, validations and qualifications, as appropriate, including life-cycle management.
- Evaluate and manage material associated supplier changes notifications to maintain GMP compliance.
- Support cryogenics and cold-chain transportation related lab studies or activities.
- Assist material and cryogenics manufacturing investigations.
- Author and revise CMC documents as appropriate.
- Author protocols, reports, and technical presentations.
Benefits
- Health insurance
- holiday pay
- 401(k) program
- Employee referral bonus program
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What This Job Offers
Career Level
Entry Level
