Director, Analytical Development

5 days ago

Boston, United States Vertex Full time

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, or
  • Masters Degree (or equivalent degree) and 12+ years of relevant employment experience, or
  • Bachelors Degree (or equivalent degree) and 15+ years of relevant employment experience

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