Research Scientist, Cell and Gene Therapy Analytical (Contract)

Job Description

Job Description

This Research 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 microbiology related analytical 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 key 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
• Author and/or review regulatory filing/response
Knowledge and Skills:
• Hands-on experience and In-depth knowledge of microbiology or potency 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

Requirements

Education and Experience:

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

• Minimum 8 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.