Associate Director, Analytical Development

Associate Director, Analytical CMC Strategy

Vertex Pharmaceuticals is seeking a highly motivated, collaborative, and innovative Associate Director specializing in analytical CMC strategy to provide scientific leadership within and across functional areas. The Associate Director, Analytical CMC Strategy is the primary analytical liaison for their program(s) and will lead, coordinate, monitor, and collaborate cross-functionally to develop analytical CMC strategies while also providing tactical direction for the execution of the analytical project plan. This is a key leadership position where the incumbent will communicate and execute the analytical strategy and will involve routine interaction with senior management. In this matrix leadership role, the candidate will act as the Analytical Product Lead (APL) and have primary responsibility for overseeing programs through the late-stage drug development lifecycle, Marketing Authorisation / Biologics Licensure application (MAA / BLA), and Life Cycle management.

Key Responsibilities

• Leading the development of the analytical CMC strategy for specific product(s), project planning, setting priorities, establishing team goals, and assuring both timeliness and high quality of deliverables for late-stage and commercial programs.
• Providing scientific leadership within and across functional areas to develop and successfully execute, in conjunction with the analytical development and Life Cycle management functional areas, an analytical strategy to support product commercialization
• Contributing to the regulatory CMC strategy and the preparation of global regulatory submissions, with clear and accurate source documentation, for the late-stage and commercial program(s) in analytical CMC subject areas including registrational CQAs, control strategy and justification of specifications, comparability studies, and stability studies according to subject matter understanding and regulatory guidelines.
• Representing the commercial team at the program level and internal governance bodies. Establish and communicate analytical program goals, key issues and risks, and ensure operational plans are in place to execute the analytical strategy for the program(s). Identify, and escalate key issues and risks to the program team and management.
• Build and maintain strong collaborations across the organization, including key stakeholders in commercial and development functions, Regulatory and Quality teams, peers, and senior management.
• Identify and implement improvements that optimize product development and commercial supply processes.

Qualifications

Pay Range : $152,800 - $229,200

Disclosure Statement : The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation : Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status : In this Hybrid-Eligible role, you can choose to be designated as : 1. Hybrid : work remotely up to two days per week; or select 2. On-Site : 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.

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.