Manager, External Manufacturing (Contract)
Supply Chain Management | Philadelphia, PA | Contract
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™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @Allogene on Twitter and LinkedIn.
Allogene’s Supply Chain 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 Manager, External Manufacturing (Manufacturing Technical Oversight (PIP)). This role will be a hands-on role reporting to the Associate Director, External Manufacturing. The main mission of the position will be to provide on-site support to our site management team that oversees Allogene’s external manufacturing operations, assist in foster strong working relationships and liaise with cross functional site management teams.
The position will be accountable for manufacturing oversight of CAR T manufacturing operations and related processes (ie: raw material receipts, raw material staging for production, perform physical inventory checks, and drug product shipments). The position is based at in the Philadelphia, PA area.
Responsibilities include, but are not limited to:
- Support the oversight of external manufacturing partners to assure on-time quality supply which meets quality, compliance and regulatory requirements
- Direct oversight on shop floor of CAR-T manufacturing execution in a sterile facility, ensuring adherence to established batch records and compliance to GMP’s. May require work during non-standard working hours and/or weekends.
- Lead cross-functional Daily Huddles comprised of Quality, Supply Chain, MSAT, etc. to ensure Allogene objectives are met in accordance with Allogene CMO governance and oversight practices.
- Lead after action review meetings after production runs, documenting outcomes and tracking action items to closure. Work with CDMO to identify and track to closure all corrective actions.
- Through frequent presence on site, establish professional and technical credibility and build sustainable, positive relationships in order to achieve defined program objectives.
- Perform manufacturing review of executed batch records and discrepancy documents. Provide SME input into the resolution of non-conformance events.
- Closely partner with the Quality Assurance group, manage and ensure the timely review and release of product from external manufacturing partners.
- Perform verification of GMP raw materials staged in manufacturing area, receipt of critical raw materials, and shipments of drug product from CDMO. Requires presence on-site at CDMO.
- Proactively develop, manage and improve contract manufacturer performance. Lead continuous improvement projects.
- Other duties as assigned
- Bachelor’s degree in Science or Engineering with a minimum of 5 years of related GMP pharmaceutical manufacturing experience. Shop floor manufacturing experience in an operations, QA, or MSAT role is highly desirable.
- Aseptic processing experience including gowning practices is required. Knowledge of cell / gene therapy processes is a plus.
- Strong knowledge of GMP practices is required.
- Highly developed leadership skills with the ability to effectively organize and lead teams without direct reporting relationships.
- Excellent written and verbal communication skills. Ability to author relevant sections of non-conformance events and team minutes is required.
- Project management experience is a plus. Ability to effectively track action items is required.
- 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
As an equal opportunity employer, Allogene Inc. 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.