Process Engineer (Contract)
Process and Product Development | South San Francisco, CA | Contract
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.
Allogene is seeking a Process Engineer to join our Manufacturing Science and Technology group and contribute to the commercialization of allogeneic CAR T therapies. This individual will lead/support various aspects of technology transfer, validation, and manufacturing support activities. He/she will work closely with internal and external partners to ensure the development and execution of a master validation plan, and the subsequent execution of process performance qualification (PPQ) runs and continuous verification activities. This is an onsite contract role that we anticipate will be 40 hours a week for 6 – 12 months.
Responsibilities include, but are not limited to:
- Collaborate with process engineers and data management team to ensure data infrastructure is structured to facilitate data analysis and competitive intelligence.
- Support collaboration between functional groups to drive a coherent data strategy that will enable streamlined data access, process monitoring, and automated reporting.
- Develop efficient data entry mechanisms to integrate historical data with the current data strategy.
- Work with teams to ensure the data strategy supports technology transfer, trouble-shooting and continuous improvement of GMP manufacturing processes
- Assist with the implementation and evolution of an integrated control strategy for allogeneic CAR-T therapies.
- Provide reliable process requirement inputs to support business case and capital project decision-making
- Assist engineers with data acquisition to ensure technically strong and compliant justifications for manufacturing deviations
- Other duties as assigned
Position Requirements & Experience:
- Chemical engineer with interest in cell therapy and biologics
- Interest in data science and basic statistics.
- Prior experience with software to support data science such as R and/or Python.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work both 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.
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.