Job Title: Senior Director, Head of External Operations
About the Job
* Lead global manufacturing and packaging operations for commercial and clinical products.
* Ensure timely delivery of quality products from Contract Manufacturing locations globally.
* Develop and implement strategic plans to reduce lead time, costs, and enhance metrics across CMO operations.
Responsibilities:
1. Provide leadership for all manufacturing and packaging operations which take place in Contract Manufacturing locations globally.
2. Ensure timely delivery of quality commercial and clinical product to support patient supply from our CMO network.
3. Manage the trades offs & risks between longer-term strategic programs & day-to-day supply activities.
4. Develop the Operations model supporting the teams as they look to standardise work, eliminate waste and focus on cross functional working relationships to ensure product supply.
5. Recruit, onboard, & train operations professionals to ensure the team has the appropriate experience & capabilities to provide oversight across the E2 E pharmaceutical value chain.
Key Qualifications:
* Bachelor's degree in a Life Sciences, Chemistry, Chemical Engineering or Pharmaceutical Engineering discipline required.
* Minimum of 15 years of relevant biotechnology or pharmaceutical industry experience within operations, quality, or supply chain.
* 10+ years of direct experience in a GMP manufacturing environment and 7+ years of team leadership.
Benefits:
* Experience overseeing multiple product launch / NPI / Tech Transfer programs.
* Experience with regulatory agency inspections (e.g., FDA, TGA).
* Previous experience leading global teams in multiple locations.
Requirements:
* Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing talent.
* Excellent written and verbal communication skills at all levels in the organization.
Location: Remote with travel to HQ in San Rafael California up to 6 times per year.
Ability to travel to CMOs up to 25-50%, when required.