|Department:||Research and Development|
The CMC consultant will be responsible for the planning and execution of drug substance and drug product CMC development, to support progression of clinical and preclinical candidates. The CMC Consultant will collaborate with Aevi project team members, external consultants, and contract service providers to define the drug substance and drug product manufacturing process and control strategy. Responsibilities include:
- Manage collaboration with contract service providers on drug substance development activities, including but not limited to polymorph screening/phase selection, physical property attribute definition, identification and synthesis of process impurities, assessment of genotoxicity potential.
- Review and approve process development reports and ensure that these are adequate to support regulatory filing.
- Provide technical oversight on manufacturing batch record review
- Contribute to process study design and evaluation
- Manage drug substance reference standard inventory and distribution
- Identify drug substance and drug product critical quality attributes impacting safety, efficacy, and manufacturing robustness. Establish phase appropriate regulatory specifications.
- Identify opportunities to optimize the drug substance manufacturing and drug product process, focusing on patient safety/efficacy and process economics.
- Author drug substance and drug product CTD modules to support regulatory submissions (IND through NDA). Respond to questions from regulatory authorities.
- Author drug substance and drug product background information to facilitate productive discussions with regulatory authorities.
- Develop and maintain a comprehensive understanding of regulatory guidance pertaining to drug substance and drug product development and commercialization.
- Collaborate with project teams to meet project objectives, budget, and timelines.