A Director ( or Associate Director) in Vertex Process Chemistry will successfully lead a group of scientists developing the technology for chemical processes to enable the safe and efficient preparation of drug substance (DS). The technology developed over time will lead to the successful manufacture of DS through design of new syntheses and process improvements to achieve bulk and quality goals for compound deliveries. A Director will effectively guide the scientific staff on chemistry and career development through leadership, personal development, goal setting and ensure training on technical and scientific topics, regulatory issues and relevance of cGMPs to the area. The Director may generate technology while doing chemistry (hands-on), direct and transfer the work to outside CRO’s for delivery of multi-kilograms of drug substance. The Director may represent Process Chemistry on cross-functional teams and/or lead cross-functional teams, both within Vertex and with alliance or vendor partners.
Interacting with R&D management to bring projects forward
Mentoring on scientific and ethical development, motivating staff and resolving conflict
Effectively directing the timely and ethical communication of scientific material through publications and patents
Effectively managing the groups’ CRO contracts and/or other external collaborations
Working with scientists to maintain standards for all laboratory records, internal reports, patents and external communications
Leading the preparation of scientific reports for all branches and levels of the organization and its collaborators
Working with project teams to identify drug substance requirements, managing and optimizing aggressive project timelines, overseeing the development of technical solutions to insure that API processes can be successfully demonstrated and delivered.
Overseeing the preparation and review of development history and regulatory documents; assisting in the writing of process descriptions for the CMC section of regulatory documents
Ensuring that all development and manufacturing activities are conducted in a manner consistent with regulatory requirements while integrating quality by design and quality risk management principles into the development of the API process
Assisting in the development and communication of department goals and strategy
Integrating activities across various departments to develop compounds
Identify and recruit talented scientist for the department.
Experience in conducting early and late phase development (IND/CTA through filings)
Other duties as defined.
Title and level commensurate with experience.
Minimum Qualifications
PhD in Organic Chemistry with10 plus years of relevant experience in process chemistry within the pharmaceutical industry.
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