Manager, External Manufacturing (Contract) (Remote)
Supply Chain Management | South San Francisco, CA | Contract
About Allogene Therapeutics, Inc:
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 @AllogeneTx 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. This role will be a hands-on role reporting to the Director, External Manufacturing. The successful candidate will be detail-driven and have a proven track record in managing and driving project success within the biotech industry. We are seeking an individual with a technical background, solid working knowledge of GMPs, understanding of the drug development pathway through commercialization, experience interacting with external manufacturers/service providers, and willingness to pivot as priorities change. A strong understanding of risk management will be an asset. The successful candidate will have excellent communication skills, written and verbal, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams.
The position will be accountable for manufacturing oversight of viral vectors and gene-editing materials and related processes.
Responsibilities include, but are not limited to:
- Support the oversight of external manufacturing activities at CDMOs to assure on-time quality supply which meets quality, compliance and regulatory requirements
- Coordinate the generation, review, execution and completion of scope of work (SOW) documents, corresponding purchase orders, invoicing and any necessary change orders.
- Establish and ensure adherence to MSAs, SOWs, and other manufacturing agreements. Track CDMO related activities and deliverables relative to budget and Company objectives.
- Direct business agreements, manage budget & cost control and improve COGs development.
- Lead cross-functional Huddles to ensure Allogene objectives are met in accordance with Allogene CDMO 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.
- Closely partner with the Quality Assurance team, manage and ensure the timely review and release of product from external manufacturing partners.
- Proactively develop, manage, track, and improve CDMO performance. Set milestones and monitor KPIs. Report out CDMO Manufacturing updates.
- Participate in the CDMO selection process by evaluating CDMO capabilities against technical requirements.
- 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 desirable.
- Prior work experience with viral vectors/gene therapy highly desired, preferably additional knowledge in late stage/commercial activities and plasmid manufacturing preferred.
- Strong knowledge of GMP practices is required.
- Must have a demonstrated ability to organize external resources to maximize quality and efficiency; maintain an overview of the entire process when planning a project, setting both short and long-term goals
- 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.
- Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables
- Ability to work independently and as part of a team
- CDMO management with up to 25% travel commitments and working in a highly matrixed organization.
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.