Title: Associate Director/Director Process Chemistry
Location: Waltham, MA
Associate Director/Director Process Chemistry
This position will be responsible for developing chemical processes to enable the safe and efficient preparation of drug substance to achieve high quality active pharmaceutical compounds for development, non-clinical, clinical activities.
- Working with project teams to identify drug substance requirements, managing and optimizing aggressive project timelines
- Oversees the development of technical solutions to ensure API processes can be demonstrated and delivered
- Oversees the preparation and review of regulatory documents – assists in the writing of process descriptions for the CMC section of regulatory documents
- Ensure 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 in the API process
- Manage external resources and collaborators
Knowledge and Skills
The idea candidate will have the following qualifications
- MS or PhD in organic chemistry with 10-15 years of experience in process chemistry in the pharmaceutical field, working on projects from pre-clinical to Phase 3/NDA phase with a minimum of 5 years’ experience working in a GMP environment.
- Experience working in a virtual CMC company environment with external manufacturers/CMOs.
- Extensive knowledge of fundamental process chemistry concepts, including, but not limited to: organic chemistry, reaction mechanisms, kinetics, thermodynamics, fluid mixing and heat transfer.
- Excellent understanding of FDA, EMA and ICH guidance documents and the ability to apply sound regulatory strategies to process chemistry problems.
- Experience inventing, troubleshooting and optimizing organic chemistry processes from mg to multi-kilogram scale.
- Knowledgeable about the available analytical techniques required for raw material, in-process and release of pharmaceutical compounds. Solid knowledge of quality assurance regulations.
- Experienced in the identification and control of impurities in a manner consistent with existing regulatory guidance.
- Experience reviewing, correcting and approving GMP manufacturing batch records
- Experience working with multi-functional teams including, but not limited to: formulation development, analytical development, material management, non-clinical, clinical personnel.
- Excellent written, oral and document control skills.
- Experience auditing potential GMP drug substance manufacturers.
- Experience in technical writing, including but not limited to, process development reports and characterization reports.
- Experience with regulatory writing such as INDs, IMPDs, and FDA briefing documents; NDA writing a plus
- Experience with drug substance validation and design of experiments a plus