Associate Director, Analytical Development, Biologics

Vertex Inc.•Boston, MA

48d•Onsite

About The Position

Vertex is seeking a talented and experienced leader to join our Analytical Development Team to lead Biologic project CMC analytical development activities. The experienced leader will play a central role in advancing our biologics projects by executing development activities through a combined internal and external network. The individual is expected to closely work with external partners in developing and executing the development activities of biologics from the discovery interface to first license approval and beyond. The individual is expected to lead the execution of analytical activities according to phase appropriate development strategies. 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 communication skills, 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 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 technical leader.

Requirements

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
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.
6-8+ years (PhD) or 9+ 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.

Responsibilities

Leads an analytical matrix team in execution of biologics analytical development
Partnering with internal and external labs in executing analytical development activities, including designing, planning, and executing all analytical activities that 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
Maintain a strong internal and external network for the execution of analytical activities

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