Scientist

2 weeks ago


Boston, United States Planet Pharma Full time

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:

  • 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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