Senior Manager, CMC Lead
Operations | South San Francisco, CA | Full Time
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.
We are seeking a highly motivated individual for the role of Senior Manager, CMC Lead to work in this exciting new area of cancer immunotherapy. The CMC Lead will facilitate product development and commercialization by directing the planning and execution of the CMC strategy for one or more pipeline therapeutics. The CMC Lead will be responsible for ensuring delivery of CMC activities in support of the global product strategy and will partner with the Technical Operations teams to execute on product development. This position reports to our Executive Director, Operations Strategy and is based out of our headquarters in South San Francisco, CA.
Responsibilities include, but are not limited to:
- Develop and execute the CMC product strategy for one or more products, including development of goals and delivery of timelines, budget, and risk assessment/mitigation
- Lead cross-functional Technical Operations team(s), including Product & Process Development, Manufacturing, Quality, and Supply Chain, and drive decision-making in support of the product strategy
- Provide Technical Operations input into, and influence, the broader global product strategy and ensure all applicable CMC requirements are appropriately incorporated into clinical/commercial products
- Work with Technical Operations partners to ensure that product is efficiently supplied to all non-clinical, clinical, and commercial sites
- Contribute to planning, organization and preparation of the CMC sections for global regulatory filings (e.g. IND, IMPD, BLA, CMC changes)
- Provide leadership/coordination with CMC authors and reviewers to ensure timely delivery of documents and data required for regulatory submissions
- Develop innovative CMC strategies and communicate throughout the organization to ensure cross-functional alignment; serve as primary point of contact for all CMC-related issues
- Proactively identify issues with respect to CMC projects, develop solutions and drive to resolution
- Lead and/or participate in strategic cross-functional project teams as needed to assess strategic CMC alternatives
- Coordinate and/or lead communication between global functional areas and corporate partners where applicable. Coordinate activities for writing data summaries or presentations for external collaboration meetings, etc., where applicable
- Create and maintain CMC product timelines, in partnership with Technical Operations and Regulatory teams
- Other duties as assigned
Position Requirements & Experience:
- BS in Life Sciences or related field required (or relevant experience), MBA a plus
- 6+ years of experience in similar role in biotechnology industry
- Global experience preferred
- Highly motivated and able to work in a fast-paced environment with a desire to learn and tackle new challenges
- Strong analytical skills and the ability to drive strategy as well as manage detailed and complex planning
- Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment
- Excellent organizational skills, and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a cross-functional team
- Candidates must be authorized to work in the U.S.
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.