Scientist, Cell and Gene Therapy Analytical
3 weeks ago
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 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.
Pay Range:
$46 - $50/HR
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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No C2C or Third-Party Vendors
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