Principal Engineer, Drug Product Process Development
Process and Product Development | South San Francisco, 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 individual for the role of Principal Engineer, Drug Product Process Development to work in this exciting new area of allogeneic cell therapy. In this role, you will be responsible for leading the strategy and execution of drug product process design. Applicants should have experience in aseptic processing, technology transfer, formulation, fill/finish and visual inspection process development. This will involve the planning, design, execution, and documentation of studies related to formulation development, drug product design, in support of AlloCAR T™ clinical supply and commercialization. This position will also contribute to the development of novel technologies and approaches to meet future AlloCAR T products.
- Lead the development of technical strategy and implementation of drug product aseptic filling processes to support AlloCAR T™ clinical product manufacturing and commercialization
- Lead and participate in the planning, design, execution, and documentation of formulation and drug product process development studies
- Design and lead execution of drug product process design using appropriate scale-down models, DOE and QBD principles
- Develop predictive modeling of drug product process unit operations as needed
- Support scale-up & scale-down model for drug product manufacturing processes (e.g. Fill/finish, Cryopreservation)
- Provide support for drug product process technology transfer and serve as person-in-plant as required
- Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of regulatory filings and marketing application submissions
- Support the introduction of new products and technologies into the facility. Troubleshoot and perform an initial assessment of events that have the potential to impact safety and product quality
- Provide support to drug product manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process improvements
- Work collaboratively and effectively in a cross-functional team environment to progress product development
- Present progress to team and management for awareness and engagement related to progress, status, and future needs
- Master’s Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline with 8+ years of relevant industry experience OR Bachelor’s Degree with 10+ years of relevant industry experience
- Experience working in the pharmaceutical or biotechnology industry that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments
- Experience with the unit operation (i.e. filling, filtration, mixing, etc.) specific scale-down models, characterization, and scale-up
- Understanding of how process-related stress impacts molecule attributes and product quality
- Aseptic processing experience and knowledge of cGMPs
- Experience with large molecules is required and experience with cell therapies is a plus
- Proficiency in statistical software (ie. JMP, or similar)
- Authored regulatory filings and compliance issues for sterile injectable products
- Prior experience with supporting the introduction of new products and technologies into facilities
- Troubleshoot and perform an initial assessment of events that have the potential to impact area safety and product quality
- Assessing departmental utilization to execute both near-term schedule and long-term strategy.
- 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.
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.