Analytical Science and Technology Associate Director (Contract)

This Consultant will be at the level of Associate Director, joining the Analytical Science and Technology (ASAT) team within the Commercial Manufacturing & Supply Chain (CMSC) department. S/He will provide expertise in assay development and validation of rapid microbiology safety methods (including but not limited to BacT Sterility and Biofire mycoplasma), and E2E analytical supports of the safety methods to the commercial manufacturing release for the Biologics and Cell & Gene therapy (CGT) portfolio.

This is a contract role for 24 months. 

20 hours per week.

Key Responsibilities:

• Be a Subject Matter Expertise (SME) and represent ASAT to lead and participate in method development, validation/verification, transfer, and submission of the rapid safety methods, including but not limited to BacT Sterility and Biofire mycoplasma.
• Strategize the analytical network for rapid microbiology safety methods and lead the network capacity expansion, including equipment IQ/OQ/PQ for commercial release.
• Author and/or review technical documents, including method SOPs, study protocols, and technical reports
• Author and/or review regulatory documents
• Provide SME assessment for deviations and CAPAs.
• Participate in internal and external meetings.

Knowledge and Skills:

• Hands-on experience and In-depth knowledge of Biofire mycoplasma, BacT Sterility, and other safety methods for the Biologics and Cell & Gene therapy (CGT) portfolio
• Expertise in testing, method verifications/validations, method compatibility, and product release specifications for the Safety methods
• In-depth knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept for the safety methods
• Excellent technical writing skills are essential
• Experience in Gene and Cell therapy is desirable
• 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

Education and Experience:

• BS or above in Biology, Biochemistry, Analytical Chemistry, and related fields.
• Minimum 12 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.

$90-$110/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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