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Scientist, Cell and Gene Therapy Analytical

Boston, MA 02210

Posted: 05/15/2024 Employment Type: Contract Job Category: Scientific Job Number: 606895 Is job remote?: No Country: United States

Job Description

Pay Rate $38-57
This Scientist position will be part of Analytical Science and Technology (ASAT) team within Commercial Manufacturing & Supply Chain (CMSC) department. S/He will provide expertise in certain analytical area supports to the commercial manufacturing and product release for the Cell and Gene therapy (CGT) portfolio.

 

Key Responsibilities:

· Work independently or in collaboration with internal and/or external partners in analytical lifecycle activities including method development, validation, and method transfer

· Be a Subject Matter Expertise (SME) and represent ASAT to participate in troubleshooting and OOS investigation occurred during release and/or stability testing

· Provide SME assessment for deviation, CAPA and change control

· Participate in internal and external meeting

· Author and/or review technical documents, including method SOP, study protocol and technical report

 

Knowledge and Skills:

· Hands-on experience and In-depth knowledge of potency or microbiology assays

· Experience in Gene and Cell therapy is desirable

· Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept.

· Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing

· Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency

· Partners effectively with internal and external functions

· Experience of using JMP or similar statistical tools is plus

· Good technical writing skills

 

Education and Experience:

· B.S or above in Biology and related field.

· Minimum 4 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.

 
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