Senior Manager, External Manufacturing

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.

Responsibilities

• 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

Requirements & Experience

• Bachelor’s degree in science or engineering with a minimum of 8 years 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 to 20%