Director, Process Development
Process and Product Development | Remote, CA | Full Time
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 a 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 technical leader to join Allogene’s Process development organization to lead the development of a critical monoclonal antibody that is administered prior to treatment with AlloCART therapy. This position is based from our headquarters in South San Francisco, but we are open to having someone work remotely and travel as needed to the office.
To ensure the commercialization of the monoclonal antibody timeline with CART, this leader will guide and oversee all technical development activities at the CDMO and any other third parties involved. Scope of end-to-end activities include oversight of cell line, drug substance, formulation & drug product development including characterization of product attributes in support of successful BLA filing.
- Leadership and oversight of the technical CMC team in support of rapid process development, including risk assessments, late-stage process development including process characterization of DS, DP performed at CMO
- Support of DS/DP validation campaign
- Technical review of reports authored at CMO
- Regular refreshment of CMC activity sequencing for efficiency and speed to ensure timelines are maintained
- Periodic communication of activities at CMO to headquarters to ensure alignment and understanding of risks/tradeoffs
- Other duties as assigned
- PhD in life sciences or engineering (or equivalent experience) with at least 15 years of experience in recombinant protein process development with at least 5 of those years leading a team
- Ability to build, manage and a mentor a team of scientists
- Prior experience with process characterization and demonstrated abilities in risk analysis
- Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines
- Strong influencing skills and ability to work in a matrixed environment
- Ability to work independently and as part of a team
- Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization
- 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.