Associate Director, CMC, Drug Substance

Role

Associate Director, CMC, Drug Substance, to oversee development and manufacturing of small molecule APIs for clinical trials in a biopharma setting.

Responsibilities

• manage API process development and cGMP manufacturing campaigns via CDMOs
• evaluate and select vendors
• facilitate technology transfer
• collaborate with supply chain to align manufacturing plans with clinical demand
• author and review regulatory CMC documents for IND/NDA/MAA submissions
• participate in audits
• manage API budgets

Requirements

• PhD in Chemistry or related field with 10+ years of pharma/biotech experience
• proven track record managing API development at CDMOs
• expertise in cGMP regulations
• authoring regulatory sections
• vendor management

Preferred

• experience with global filings
• strong communication skills
• ability to travel up to 15%
• experience in virtual manufacturing settings

HighValue

• focus on small molecule APIs
• late-stage development
• regulatory filings
• international collaboration
• API process tech transfer

WorkSetup

based in Boston, MA, with potential remote options; international travel may be required.