Must Haves:

\nMinimum BS required with 2+ years of industry experience or MSc in Chemical Engineering, Biochemical Engineering, Material Science Engineering, Chemistry or equivalent scientific background.\nStrong organizational, oral communication and technical writing skills.\nStrong attention to details, excellent experimental/troubleshooting aptitude, and be self-motivated.\nPharma background required.

Job Description:

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.\n
The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement groups on cross-functional teams.\nThe subject matter expert for this position will be primarily required to:\n
Support material and cryogenics technical evaluations, risk assessment and change management activities\n
Executes material control strategies, validations and qualifications, as appropriate, including life-cycle management.\n
Evaluate and manage material associated supplier changes notifications to maintain GMP compliance.\n
Support cryogenics and cold-chain transportation related lab studies or activities.\n
Assist material and cryogenics manufacturing investigations.\n
Author and revise CMC documents as appropriate.\n
Author protocols, reports, and technical presentations.

Education:

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

Requirements:

Awareness of cGMP compliance and regulatory agency requirements.\n
Knowledge of common protein analytical tools and demonstrated experimental skills for lab work are required.\n
Knowledge of manufacturing process validation desired.\n
Strong organizational, oral communication and technical writing skills. Strong attention to details, excellent experimental/troubleshooting aptitude, and be self-motivated.\n
Effective team player and strong individual contributor.

EEO:

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