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 world-class 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.
Reporting to the Executive Director, Operations Strategy, the Senior Manager, CMC Lead will facilitate product development and commercialization by leading 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 Operations Technology teams to execute on product development.
Responsibilities include, but are not limited to:
- Partner with CMC functions 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
- Manager cross-functional Operations Technology 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 the broader global product strategy and ensure all applicable CMC requirements are appropriately incorporated into clinical/commercial products
- Work with Operations Technology 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 (eg IND, IMPD, BLA, CMC changes)
- Coordinate with Regulatory partners and 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
- Manage and/or participate in strategic cross-functional project teams as needed to assess strategic CMC alternatives
- Coordinate communication between global functional areas and corporate partners
- Coordinate activities for writing data summaries or presentations for external collaboration meetings, etc.
- Other duties as assigned
Position Requirements & Experience:
- BS in Life Sciences or related field required (or relevant experience)
- 6+ years of experience in similar role in biotechnology industry supporting Operations Technology and/or Project Management functions
- Experience managing external partnerships
- Global experience preferred
- PMP certification or MBA a plus
- 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 team
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S.