Director, Analytical Development - Biologics, Cell & Gene Therapy

Job Description Vertex Pharmaceuticals is seeking an analytical development director to join our analytical development team in our cell and gene therapy organization. This position is expected to provide key technical leadership in advancing our biophysical and biochemical CMC analytical development capacities. Extensive experience in analytical development for biologics, including ADC and complex proteins is desired. Strong technical expertise in bio-separation science, Mass Spec characterizations, biophysical and biochemical analysis is desired. The individual in this role will collaborate closely with research, process development, manufacturing, regulatory and quality to develop and innovate Vertex's next generation CT products. Key Responsibilities: Provide science-based recommendations to aid in the advancement of assets to the clinic. Provide strong expertise in mass spec and biophysical characterization of biologics and CT products. Provide strong expertise in developing product characterization packages for biologics and CT products. Strong expertise in analytical method developments for biologics purity and impurity analysis. Strong expertise in experimental design, protein degradation pathways, CQA determination. Contribute to design analytical strategy of biologics and CT products. Author CMC section of regulatory filings. Collaborate with research and process development to develop fit-for-purpose analytical methods for target optimization and manufacture process development. Collaborate with quality to develop and qualify analytical methods for product release and stability. Oversee and lead a team of scientists and technical specialists in the evaluation and implementation of analytical procedures relevant to product characterization and qualification testing. Establish strong relationships and collaborate closely across multiple functions as well as externally with partners. Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods. Recruit and mentor talent and manage analytical sciences function with needed capabilities. Education and Experience: Bachelor's degree, Master's degree or PhD in Analytical Chemistry or related field. Ph.D. (or equivalent degree) and 9+ years of relevant post-doctoral employment experience, or Master's Degree (or equivalent degree) and 12+ years of relevant employment experience, or Bachelor's Degree (or equivalent degree) and 15+ years of relevant employment experience. Experience in CMC analytical development of gene & cell therapies, or biologics products. Strong expertise in biologics characterization is a must. Experience in a broad variety of analytical techniques. Excellent problem-solving skills. Excellent communication skills to communicate across multiple functional areas. Flex Designation:

On-Site Designated Flex Eligibility Status:

In this

On-Site

designated role, you will work

five days per week on-site

with ad hoc flexibility. Company Information: Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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