- 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
- 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
- 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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Scientist - Boston, United States - Planet Pharma
Description
Scientist needed
Summary:
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:
Knowledge and Skills:
Education and Experience: