Director, Analytical Development, Biologics

Job Description

General Summary:

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 execution 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:

• Excellent communication skills and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts
• Track-record in leading cross-functional matrix team
• Track record in developing analytical phase appropriate strategy for biologics development
• Excellent problem-solving skills in biologics development
• Deep technical understanding of analytical methodologies, such as LC, iCE, CE-SDS, ELISA, PCR, particulates etc.
• Deep technical expertise to lead analytical method validation and analytical transfer, establish analytical control strategy, design stability programs and comparability studies.
• Experience authoring CMC sections of regulatory documents.
• Experience of Regulatory guidelines relevant to biologics development
• Knowledge of cGMP requirements
• 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
• The ability to work in a dynamic, fast pace, matrix environment, manage priorities and maintain timelines for multiple projects.

Education and Experience:

• 11+ years (PhD) or 15+ years (MS) in relevant discipline (analytical, biochemistry, molecular biology, biotechnology or related field) with progressive experience in technical leadership roles in the biotech industry, and specifically in the development of analytical control strategies. Experience with Biological products CMC development is critical.

#LI-BS1

Pay Range:

$197,500 - $296,200

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