Job Summary:
This Sr.Scientist/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 assay development and validation and E2E analytical supports to the commercial manufacturing and critical component 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
• Author and/or review technical documents, including method SOP, study protocol and technical report
• 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
• Perform data trending analysis
• Participate in internal and external meeting

Knowledge and Skills:

• Excellent technical writing skills are essential
• Hands-on experience and In-depth knowledge of protein and gRNA analysis required
• 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 a plus
• Experience with NGS technology is a plus

Education and Experience:
B.S or above in Biology, Biochemistry, Analytical Chemistry and related fields.
Minimum 8 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.

$48 - $55/HR

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