Assistant/Associate Scientist

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.

• Minimum BS required with 2+ years of industry experience or MSc in Chemical Engineering, Biochemical Engineering, Material Science Engineering, Chemistry or equivalent scientific background

• Awareness of cGMP compliance and regulatory agency requirements.
• Knowledge of common protein analytical tools and demonstrated experimental skills for lab work are required.
• Knowledge of manufacturing process validation desired.
• 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.

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