Senior Manager, External Manufacturing

Job Description

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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

About the role:

Allogene’s Manufacturing 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, External Manufacturing. This role will be a hands-on role reporting to the Director, External Manufacturing & Technology and will oversee external manufacturing operations, with a focus on gene-editing and late-stage qualification.

The position will be accountable for managing the business and technical aspects of CDMO site management and coordinating all cross-functional activities related to the support of manufacturing operations. The position is based at Allogene headquarters in South San Francisco or in Newark, California.

Responsibilities include, but are not limited to:

• Oversight of external manufacturing partners to ensure on-time 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 on-site presence (as required), 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 and SOWs
• Closely partner with the Quality Assurance group, manage and ensure the timely review and release of product from external manufacturing partners and ensure implementation of CAPAs
• Proactively develop, manage and improve contract manufacturer performance. Set targets and monitor KPIs. Lead continuous improvement projects.
• Communicate changes and issues with suppliers and contract sites
• 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
• Manage all financial flows with the CDMO and partner with Finance to develop and monitor site budgets.
• Engage with broader manufacturing team to enable accomplishment of department goals
• Other duties as assigned

Position Requirements & Experience:

• Bachelor’s degree in science or engineering with a minimum of 8years of directly related GMP pharmaceutical manufacturing experience. Direct experience with RNA and/or protein manufacturing preferred.
• Knowledge of pharmaceutical manufacturing processes. Knowledge of cell / gene therapy processes preferred.
• Experience managing external manufacturing/CDMOs for biologics or cell therapy.
• Late-stage clinical and commercial experience preferred.
• Experience with CMC regulatory submissions preferred.
• Highly developed leadership skills with the ability to effectively organize and lead teams without direct reporting relationships.
• Solid financial acumen with knowledge of operational budgets
• 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 to20%
• Candidates must be authorized to work in the U.S.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $155,000 to $180,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

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, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.