Director, Analytical Development, Biologics

Analytical Development Leader For Biologics

Vertex is seeking a talented and experienced leader to join our Analytical Development Team to lead CMC analytical development for biologics. The experienced leader will play a central role in advancing our biologics portfolio by building analytical development strategies through a combined internal and external network. The individual is responsible for providing strategic and technical leadership for analytical development of biologics from the discovery interface to first license approval and beyond, such as post approval 2nd generation product development. The individual is expected to lead multiple analytical matrix team leaders, in defining and executing analytical development strategies with phase appropriate development approaches.

The successful candidate must work well in a fast-paced, integrated team environment. Strong experience in managing external CRO / CTO is a must. The individual is expected to drive effectively with external partners in the execution of analytical development activities for multiple programs. The candidate must demonstrate strong technical expertise in state-of-art analytical methodologies and problem-solving skills. Strong technical background is desired in the area of analytical techniques commonly used in the analysis of biologics products, along with data analysis and statistics used in product specification setting.

The candidate is expected to collaborate closely with the Research, Process Development, Manufacturing, Quality, Regulatory functions to develop and deliver products to the clinical. 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 analytical strategy development of biologics
• Partnering with internal and external labs in executing analytical development activities, including designing, planning, and executing all analytical activities that can lead to successful IND / IMPD and / or BLA / MAA applications.
• Authors CMC sections of regulatory submissions. Ensures that all regulated work and documents conform to GMP standards
• Proactive resource planning to align with established development strategy
• Planning budget proposals and manages execution of approved activities within budgets
• Maintain a strong internal and external network for the execution of analytical activities
• Mentoring a team of analytical matrix leaders. Remove roadblocks. Build strategy roadmaps in advancing technical leadership in biologics development
• 10% travel

Knowledge and Skills :

Education and Experience :

Pay Range : $197,500 - $296,200

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.