Scientist, Process Development (Contract)
Process and Product Development | South San Francisco, CA | Contract and Temporary
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 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.
Allogene is seeking a Senior Associate Scientist or Scientist to join our late state Process Development group to support process characterization of allogeneic CAR T therapies. This individual will support various aspects of process characterization, validation and manufacturing activities. He/she will work closely with internal and external partners to ensure the execution of the process characterization plan, comprehensive risk assessments, data synthesis that translates to the subsequent execution of process performance qualification (PPQ) runs and robust continuous verification and manufacturing support.
Responsibilities include, but are not limited to:
- Design and execute studies in support process characterization of processes designed to produce gene-engineered allogeneic CAR T cells.
- Develop expertise and lead studies that employ genomic engineering, media characterization, T cell activation, cell isolation/enrichment and fill/formulation.
- Design, execute, and analyze T cell characterization assays.
- Develop experimental plans, interpret results with robust statistical analysis, summarize and present data and report progress on behalf of the team under the guidance of senior scientists.
- Author and update batch records for small scale studies that model large scale manufacturing process.
- Thorough and timely documentation in electronic laboratory notebooks, technical reports and support of authoring of regulatory filings.
- Occasional weekend work to support manufacturing runs in the process development labs.
- Remain current with the relevant literature. May collaborate and author external publications and present research at external conferences.
- Support development of technical strong and compliant technical justifications for manufacturing deviations.
- Participate and contribute to technical and strategic teams.
- Other duties as assigned.
Position Requirements & Experience:
- Bachelor’s Degree with 8+ years of relevant work experience or Master’s Degree with 5+ years of relevant experience or Ph.D. in Cell Biology or an Engineering discipline.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Experience in maintaining and cross-referencing a laboratory notebook, including technical authoring of reports.
- Effective at both independent work and team-driven efforts.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Ability to work in a fast-paced startup environment.
- Candidates must be authorized to work in the U.S.
Preferred Qualifications & Experience:
- Expertise in T cell immunology and methods that facilitate characterization and functional testing.
- Expertise in cell therapy process development or methods.
- Experience in flow cytometry methods.
- Experience with statistical and numerical techniques.
- Past work with cellular manufacturing in a cGMP environment and/or work with closed, single-use manufacturing technologies.
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.