Executive Director, External Manufacturing
Supply Chain Management | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
We are seeking a highly motivated individual to join us as Executive Director, External Manufacturing. This role will be a hands-on role reporting to the SVP of Supply Chain and External Manufacturing. The main mission of the position will be to define and shape Allogene’s external manufacturing strategy for viral vectors and gene editing technologies.
Responsibilities include, but are not limited to:
- Develop and execute clinical and commercial manufacturing strategies including make vs. buy assessments.
- Lead contract negotiations with key partners including developing and negotiating development, technology transfer and manufacturing / supply contracts
- Manage teams responsible for tech transfer, process characterization and validation projects, and the investigation of process related manufacturing issues
- Oversee and lead interactions with manufacturing partners to assure on-time quality supply which meets compliance and regulatory requirements
- Establish and maintain a reliable, agile manufacturing network that can develop scalable manufacturing processes and reliably deliver material to supply research, pre-clinical, clinical and commercial needs.
- Manage executive level interactions with key partners.
- Deliver excellence in outsourced manufacturing activities, including monitoring adherence to contracts; managing the project budget, and identifying and implementing best practices
- Key member of the Supply Chain Leadership Team where they will have shared accountability for managing the business, setting the vision, and delivering its strategic roadmap
- Build a strong and scalable external manufacturing organization
- Contributing author and reviewer of regulatory filings and responding to questions received from health authorities
- 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
- Support the development and implementation of CMO management processes and governance structure
- Recruit and retain exceptional talent, create and manage high performing teams
- Determine the feasibilities of new product designs and significant product changes by managing and evaluating the global new product impacts to processes, tooling, testing, quality, and safety practices
- Establish governance structures (joint project teams, steering committee) that facilitate timely, open communication with CDMOs and internal stakeholders to enable delivery of CDMO services
- Serve as a thought partner with Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Development colleagues
Position Requirements & Experience:
- Bachelor’s degree required with at least 15 years of progressive CMC experience in a pharmaceutical company and deep cell and or gene therapy experience
- Leadership experience in building and developing high performing teams, delivering results and driving innovation and continuous improvement
- Experience managing multiple stakeholders, prioritizing responsibilities, and allocating resources to drive maximum business impact
- Demonstrated track record of building collaborative cross-functional relationships both internally and externally, willing to compromise to achieve objectives and adept at resolving conflicts
- Ability to translate complex data insights into actionable business recommendations
- Comprehensive knowledge of GxP regulations, guidance, and industry best practices
- Ability to analyze and develop solutions to complex problems
- Excellent interpersonal, verbal, written and presentation skills to explain complex concepts and findings clearly to a variety of audiences, including senior management
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.