Senior Director, Commercial Manufacturing and Operations

The role

The Senior Director, Commercial Manufacturing and Operations will build, scale, and govern the commercial manufacturing and supply platform for palazestrant. This person owns end-to-end commercial supply including drug substance, drug product, packaging, labeling, serialization, inventory, and distribution.

What you will do

• Set the commercial supply strategy for palazestrant
• Own the commercial supply budget, COGS inputs, and supply cost KPIs
• Lead supply-side launch readiness from NDA submission through PDUFA and market entry
• Provide business and operational oversight of commercial DS and DP manufacturing
• Negotiate and own commercial supply agreements
• Manage CDMO production schedules day to day
• Oversee commercial packaging and labeling vendors
• Ensure serialization, aggregation and traceability systems are validated and DSCSA-compliant
• Run the monthly supply planning (S&OP) cycle
• Manage commercial inventory hands-on

Required qualifications

• BS/MS/PhD in Chemistry, Chemical Engineering, Pharmacy or a related scientific discipline with 15+ years in pharmaceutical CMC, manufacturing or commercial supply; or a business degree with 15+ years
• Demonstrated small-molecule commercial launch experience, including registrational readiness, PPQ, process validation and the transition from late-stage development to commercial supply
• Extensive experience governing CDMOs across DS and DP
• Hands-on commercial supply chain experience: supply planning/S&OP, inventory management, 3PL and specialty distribution, and DSCSA serialization
• Strong understanding of US and global regulatory requirements for the manufacture, testing, release and control of commercial small-molecule products
• Track record of presenting recommendations, risks and mitigation scenarios to executive management
• Leadership experience

Nice to have

• US launch experience strongly preferred

Benefits

• Equity
• Bonus
• Benefits

About the company

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond.