Director, Chemical Development Job Description Template
Our company is looking for a Director, Chemical Development to join our team.
Responsibilities:
- Recommends the development of more convergent synthetic strategy to produce drug substance, and save cost and reduce waste generation;
- Conduct route scouting, reaction optimization, and scale-up demonstration using an outsourcing model;
- Supervises the implementation of development activities at CROs via reviewing and writing of clear and concise procedures;
- Provide leadership in support of Active Pharmaceutical Ingredients (API) development programs;
- assurance mechanisms when appropriate;
- Focused upon development of chemical processes to avoid reactions and processes that do not scale well, e.g. hazardous reactions;
- Responsible for deliveries of drug substance to support IND enabling toxicology studies as well as cGMP API for Phase appropriate clinical studies;
- Ensures that scientifically-sound technical data are generated that enables key decisions on early and late stage development projects.
Requirements:
- Experience in preparation and submission of CMC documents in support of global regulatory filings across development stages (e.g. IND to NDA);
- Experience with process characterization or design space studies using DoE statistical analysis tools;
- Experience in technically managing projects at development and clinical production stages;
- Strong computer, scientific, and organization skills;
- Ability to travel up to 30% both domestically and internationally;
- Demonstrated history working in a virtual CMC development and/or commercialization environment working with CMC partnerships with global providers;
- Desire to acquire new knowledge in chemistry, pilot and plant operations in different contract research organizations;
- Must be able to determine appropriate resources for resolution of problems, to have strong organizational and planning skills and work independently.