AD/Director of Process Chemistry
Summary:
Our client, a leading biotech firm in New Jersey, is seeking a strong Director of Process Chemistry to lead their team in developing and optimizing their small molecule API programs from discovery to commercialization. The Director of Process Chemistry will be responsible for overseeing a team of scientists in the development of new synthetic routes, the optimization of existing processes, and the scale-up of processes for commercial production.
Responsibilities:
- Develop and optimize synthetic routes for small molecule API processes
- Lead the scale-up of processes for commercial production
- Ensure that all processes are optimized for safety, quality, and efficiency
- Work with cross-functional teams to ensure that all projects are completed on time and within budget
- Manage CRO/CMO relationships to ensure that all work is completed to the highest standards
- Provide technical leadership and guidance to Jr. scientists on the Process Chemistry team
- Ensure that all processes are in compliance with relevant regulations and guidelines
- Author and review technical reports, regulatory submissions, and patents
Qualifications:
- Ph.D. in Synthetic Organic Chemistry or related field with +6-8 years of industry experience
- Cross functional leadership experience & proven track record of overseeing direct reports
- Strong knowledge of process chemistry for small molecule AP
- Experience with IND/IMPD/NDA filing
- Excellent communication and interpersonal skills
- Strong project management skills
- Experience with CRO/CMO selection & management