Analytical Science and Technology Associate Director – Contract

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October 3

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Vertex Pharmaceuticals

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.

1001 - 5000 employees

Founded 1989

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Provide expertise in assay development and validation of rapid microbiology safety methods • Lead and participate in method development, validation/verification, transfer, and submission of the rapid safety methods • Strategize the analytical network for rapid microbiology safety methods and lead the network capacity expansion • Author and/or review technical documents, including method SOPs and regulatory documents • Provide SME assessment for deviations and CAPAs

🎯 Requirements

• 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 • 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

🏖️ Benefits

• Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer • Overtime pay, in accordance with federal and state requirements