Senior Manager, External Manufacturing

Allogene Therapeutics•Newark, NJ

3d•Hybrid

About The Position

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.

Requirements

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%
Candidates must be authorized to work in the U.S.

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
Other duties as assigned