Job Description
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.
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