Senior Director, Analytical Development, Cell and Gene Therapies

Job Description

General Summary:

Vertex is seeking a talented and experienced leader to join our Analytical Development (AD) Biologics and Cell and Gene Therapies Team in Boston, MA. The experienced leader will be a member of the AD Leadership Team and will play a central role in advancing our programs and growing our capabilities to support manufacturing and testing of our therapies. The individual in this role will work collaboratively with Research, Process Development, Manufacturing, Quality Control, Regulatory, and Quality functions to develop and innovate next-generation analytical tools for the characterization and release of biologics and cell and gene therapy products. Responsibilities of the Senior Director will include the oversight and accountability for all deliverables assigned to the individual and/or their team, including but not limited to people management and development, departmental responsibilities, analytical project team development plans and strategy, as well as contributing scientifically in the resolution of analytical and broader drug development challenges in collaboration with other R&D functions. Knowledge of cGMPs and Regulatory guidelines is required as well as expertise in laboratory techniques commonly used in the analysis of cell and gene therapy products is required. The ability to work both independently and in a matrix team environment is essential. As a member of dynamic and diverse Analytical Development and CMC teams focused on science and innovation, this position will provide opportunities for continued learning and cross-functional collaboration enabling the individual to grow broadly beyond one's own discipline as a scientific and strategic leader.

Key Duties and Responsibilities:

• Leads all analytical aspects of cell assay development for projects assigned to the individual or their direct reports, including designing, planning, and executing IND/IMPD and/or BLA/MAA-enabling analytical activities.
• Responsible for the development, optimization, validation, and transfer of cell-based GMP-compliant analytical methods that meet global regulatory requirements for clinical stage, biologics and cell and gene therapy products.
• Authors or reviews CMC sections of regulatory submissions, responds to information requests, and authors, reviews, and/or approves SOPs. Ensures that all regulated work and documents conform to GMP standards.
• Ensure a high-performing team by developing strong technical talent, ensuring the development and implementation of training required to fully qualify staff for establishing and maintaining capable and controlled processes.
• Mentors staff on scientific development, motivates staff, and resolves conflicts; Monitors the activities of staff and provides them reliable guidance to succeed and grow
• Constructs budget proposals and manages execution of approved budgets and hiring
• Aligns team(s) activities to company priorities, and adapts resources as needed, to ensure key goals are met on time. In addition, helps craft team goals and ensures linkage to personnel goals in support of the corporate goals
• Seeks out and plans scientific direction for the team(s) and nurtures technological innovation
• Maintains the excellence of structure and interpretation of all laboratory records, electronic database entries, internal methods/reports, patents, regulatory submissions, and external communications
• Organizes preparation of scientific reports for project teams, senior management, and other departments and collaborators, and presents reviews of team progress when called upon

Knowledge and Skills:

• Demonstrated track record overseeing analytical development teams supporting early and late-stage development of cell therapies
• Deep technical understanding of analytical methods for characterizing cells (potency (bioassays), flow cytometry, cell count and viability, imaging, cell health characterization)
• Knowledge of development for key cell assays and associated requirements (validation, stability, comparability assessments, etc) across development is required, as well as extensive supervisory experience of analytical teams.
• A strategic thinker with a strong result orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide
• The ability to work in a dynamic, fast pace, matrix environment, manage priorities and maintain timelines for multiple projects.
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
• Experience authoring or overseeing authoring of CMC sections of regulatory documents. Working knowledge of quality systems requirements.
• Superior skills recruiting quality staff and refining team activities and processes to improve productivity.
• Knowledge of cGMPs and Regulatory guidelines relevant to gene and cell therapy

Education and Experience:

11+ years (PhD) or 15+ years (MS) in relevant discipline (immunology, biochemistry, cell biology, biotechnology or related field) with progressive experience in technical leadership roles in the pharmaceutical industry, and specifically in the development of analytical control strategies. Experience with Biological products or Genetic and Cell Therapy technologies is critical.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

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 ApplicationAssistance@vrtx.com