Senior Manager/Associate Director, External Manufacturing
Supply Chain Management | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene’s 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 a Senior Manager/Associate Director, External Manufacturing. This role will be a hands-on role reporting to the Vice President, Supply Chain and External Manufacturing. The main mission of the position will be to oversee Allogene’s external manufacturing operations, foster strong working relationships and lead cross function site management teams.
The position will be accountable for the oversight of CAR T manufacturing operations and related processes. The incumbent will oversee all aspects of the operation including supply, logistics, technical, quality and financial. The position is based at Allogene headquarters in South San Francisco.
Responsibilities include, but are not limited to:
- Oversee and lead interactions with external manufacturing partners to assure on-time quality supply which meets quality, compliance and regulatory requirements
- Lead cross-functional Joint Management Teams (JMTs), comprised of Quality, Supply Chain, MSAT, etc. to ensure Allogene objectives are met in accordance with Allogene CMO governance and oversight practices.
- Through continuous presence on site, establish professional and technical credibility and build sustainable, positive relationships in order to achieve defined program objectives.
- 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.
- Proactively develop, manage and improve contract manufacturer performance. Set targets and monitor KPIs. Lead continuous improvement projects.
- Oversees the timely execution of tech transfer plans in preparation for pivotal readiness and commercialization.
- 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 and contract sites
- 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
- Other duties as assigned
- Bachelor’s degree in Science with a minimum of 8 to 10 years of directly related GMP pharmaceutical manufacturing experience, including at least 4 years of management / supervisory experience
- Knowledge of pharmaceutical manufacturing processes including cell / gene therapy processes
- Process development and technology transfer experience a plus
- Highly developed leadership skills. Ability to lead in a highly matrixed cross functional team setting.
- Excellent written and verbal communication skills
- Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines.
- Ability to work independently and as part of a team.
- Ability to travel up to 25%
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact us through our careers website for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.