Research Scientist, Cell and Gene Therapy Analytical (Contract)
Apply NowCompany: BioPharma Consulting JAD Group
Location: Boston, MA 02115
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.
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.