Senior Manager, External Manufacturing

Allogene Therapeutics • Newark, NJ

5d

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.
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 Senior Manager, External Manufacturing. This role will be a hands-on role and will oversee external manufacturing operations, with a focus on 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 could be based either at Allogene headquarters in South San Francisco or Allogene’s manufacturing facility in Newark, CA

Requirements

• Bachelor’s degree in Science or Engineering with at least 8 years of directly related GMP pharmaceutical manufacturing experience (direct experience with viral vector manufacturing strongly preferred).
• Knowledge of pharmaceutical manufacturing processes.
• Experience managing external manufacturing/CDMOs for biologics or cell therapy.
• 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 organizational skills and an ability to prioritize effectively to deliver results within established timelines
• Ability to work independently and as part of a team, strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment
• Ability to travel up to 20%
• Candidates must be authorized to work in the U.S.

Nice To Haves

• Knowledge of cell / gene therapy processes preferred.
• Late-stage clinical and commercial experience preferred.
• Experience with CMC regulatory submissions preferred.

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees