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Director, External Manufacturing - Biotechnology
South San Francisco, CA 94080
The Supply Chain organization is building a world class team that is focused on delivering potentially lifesaving therapies to patients. We are seeking a highly motivated individual to join us as Director, External Manufacturing. This role will be a hands-on role reporting to the VP of Supply Chain and External Manufacturing. The main mission of the position will be to define and shape external manufacturing strategy and relationships in collaboration with contract manufacturers and functional managers.
Responsibilities include, but are not limited to:
- Oversee and lead interactions with external manufacturing partners to assure on-time quality supply which meets compliance and regulatory requirements
- Lead cross-functional Joint Management Teams (JMTs), comprised of Quality, Manufacturing, MSAT, etc. to ensure Allogene standards are met
- Establish and manage the necessary manufacturing agreements including MSAs
- Closely partner with the Quality Assurance group, manage and ensure the timely review and release of product from external manufacturing partners
- As needed, act as person in the plant for CMO start-up and manufacturing activities
- Proactively develop, manage and improve contract manufacturer performance, set targets and monitor KPIs, and lead continuous improvement projects
- Serve as primary point of communication/escalation for issues, assure the JMT has “one voice” to 3rd parties
- Set goals for JMT members with functional heads
- Develop and review metrics with suppliers and internal teams
- Communicate changes and issues with suppliers
- Ensure implementation of CAPAs
- In collaboration with Supply Planning, develop capacity analysis of the end-to-end supply chain and implement the necessary actions to ensure appropriate capacity to meet forecasted demand
- Develop sourcing recommendations
- Support the development and implementation of CMO management processes and governance structures
- Other duties as assigned
- Bachelor’s degree in Science with minimum of 10+ years of directly related GMP manufacturing experience, including at least 8 years of management/ supervisory experience
- Knowledge of GMP manufacturing processes including Drug Substance, Drug Product and Packaging
- Knowledge of aseptic manufacturing processes, experience with cell culture or viral manufacturing preferred
- Highly developed organizational and leadership skills
- Process development or technology transfer experience a plus
- Ability to travel up to 30%
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Ability to work independently and as part of a team
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.