What are the responsibilities and job description for the Associate Director, CMC Drug Product Development position at People With Chemistry?
We are partnered with a growing biotech organization that is seeking a Bay Area-based Senior Manager of CMC Drug Product Development. This role is focused on leading drug product manufacturing across their network of CDMOs. They will also represent the drug product function internally and externally. This is a great opportunity for someone who is interested in creating therapeutics for serious autoimmune and cancer indications, which are in clinical trials.
Responsibilities :
- Provide technical oversight and troubleshoot with CDMOs to ensure successful investigational product manufacturing.
- Review and evaluate process parameters, specifications, batch data, records, and trends, including addressing OOT / OOS issues.
- Author and review technical documents such as protocols, reports, risk assessments, and regulatory filings.
- Participate in identifying and selecting CDMOs and representing CMC Manufacturing in process teams.
- Translate technical manufacturing issues for broader audiences and support technical transfer processes.
Requirements :
Contact :
For a confidential discussion, please reach out to Amit at amit.uma@meetlifesciences.com or 628 336 2772.
