Scientist, Cell And Gene Therapy Analytical

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.