Title: Senior Manager, CMC Development
Location: New Jersey/ Greater New York City area
Summary:
The Senior Manager will oversee and manage all CMC projects in the formulation and process development groups, as well as the manufacturing teams. You will author the IND and IMPD regulatory filings for oral solid (OSD) and liquid dosage forms in clinical trials.
Day to Day:
- Lead all aspects of Formulation and Process Development teams, Manufacturing (Packaging and Labeling), CRO/CMO outsourcing, and regulatory authorship
- Author and review formulation reports for process optimization.
- Select CRO and CMO vendors for partnerships
- Create timelines and management strategies for API inventories and drug product availability
- Execute clinical trial supply manufacturing and packaging in collaboration with Clinical Supplies SME and organize API method transfer
You Should Have:
- BS with 9+ years of relevant experience OR advanced degree (MS or PhD) with 5+ years of industry experience
- Experience with formulation for CMC and the drug development process for clinical trials
- Familiarity with Regulatory guidelines for IND and IMPD
This role is Hybrid with 1-2 days per week in office. Must be authorized to work in the US.
