Director, Analytical Development - Cell & Gene Therapy

Director, Analytical Development - Cell & Gene Therapy page is loaded Director, Analytical Development - Cell & Gene Therapy Apply locations Boston, MA time type Full time posted on Posted 16 Days Ago job requisition id REQ-22188 Job Description General Summary: The Director, Analytical Development is a key leadership role within the Cell and Gene Therapy Analytical Development function and will be responsible for establishing and leading the company's analytical testing strategy (manual and automated), operations, and implementing testing automation capabilities. This role will work collaboratively with the Manufacturing, Process Development, Regulatory, and Quality functions to both provide high quality data to drive strategy and decisions as well as develop and innovate next generation analytical automation tools for the characterization of cell and gene therapy processes and products. This role will have opportunity to develop the analytical strategy and execute on how the company approaches the analytical development function and have an impact on broader program analytical strategies and efforts.
Key Duties and Responsibilities: Provides strategic leadership of the Testing, Operations, and Automation Analytical Development Function across multiple programs. Provides science-based recommendations to aid in the advancement of assets to the clinic.
Oversees a team of scientists who are responsible for the development, optimization, and qualification of automation analytical methods that meet regulatory requirements for clinical stage cell and gene or biologics products. May also oversee the development of non-compendial safety assays.
Oversees a team of scientists and technical specialists in the evaluation and implementation of analytical procedures relevant to product characterization testing.
Oversees and establishes testing strategies (using manual and automated methods) to support process development, process characterization, and stability studies in support of establishing process understanding and control strategies. This includes establishing data trending and visualization platforms that support interpretation of datasets.
Responsible to establish operational best practices across analytical development with respect to sample and data management, data integrity (documentation in notebooks and reports), training, and quality events (change controls, events)
Responsible to establish and manage critical assay reagents, assay controls, and control charts to ensure optimal assay performance.
Establishes strong relationships and collaborates closely across multiple functions as well as externally with partners
Authors and reviews technical and scientific documents including but not limited to study protocols and reports, and test methods.
Collaborates effectively with other CMC team members, and cross functional teams to support regulatory submissions; Represents the analytical function as needed for regulatory interaction and authors analytical sections in regulatory documents as needed.
Recruits and mentors' talent and manages analytical function with needed capabilities; Responsible for managing the department resources (budget and headcount).
Knowledge and Skills: Experience within the Pharmaceutical Industry with a proven track record of people leadership and advancing assets into the clinic; Demonstrates strong aptitude helping to lead a group or team endeavor, and building team unity
Ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple activities are required
Demonstrates excellence in his/her own scientific discipline and/or area of pursuit; Exhibits a robust understanding of scientific disciplines beyond his/her own specialty area; Broad understanding of the drug development process
Demonstrated leadership skills and verbal and written communication skills are essential; Communicates clearly and precisely (reading/writing and verbal) with all levels of the company
Good understanding of ICH, FDA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development
Excellent interpersonal and team skills are required to influence others internally/externally; Demonstrates outstanding diligence and competence in a supervisory role; Ability to work successfully in both a team/matrix environment as well as independently is required
Demonstrated track record with analytical development supporting early and late-stage development of cell and gene therapies or biologics
Derives widespread peer respect through scientific leadership and the display of high ethical standards
Education and Experience: Bachelor's degree, Masters degree or PhD in Analytical Chemistry or related field.Ph.D. (or equivalent degree) and 9+ years of relevant post-doctoral employment experience, orMasters Degree (or equivalent degree) and 12+ years of relevant employment experience, orBachelors Degree (or equivalent degree) and 15+ years of relevant employment experience#LI-onsite #LI-SV
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.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ******.
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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com  or follow us on Facebook , Twitter/X ,  LinkedIn ,  YouTube  and  Instagram . The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.  Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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