Senior Specialist, Manufacturing
Manufacturing | Newark, CA | Full Time
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 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 Manufacturing Specialist, who will be a contributing member of a team responsible for the successful technology transfer, operational readiness startup, and operation of our state-of-the-art allogeneic CAR T cell therapy manufacturing facility. The job scope includes the generation and implementation of manufacturing documentation, including batch records, logbooks, and standard operating procedures; support for implementation of manufacturing processes and systems; and assistance and troubleshooting through commissioning and qualification activities of all related processing equipment and/or analytical instrumentation used in manufacturing. The successful candidate will have experience in a regulated biotech or pharmaceutical setting and will have proven competency and expertise in the GMP manufacture of CAR T cell therapies.
This role will lead and participate in operational readiness activities related to CAR T Cell Production with Manufacturing, Quality, Process Development, Engineering, and/or IT to ensure the timely and smooth startup of the Newark facility. This role will utilize knowledge of cGMP regulations and project management skills, as well as promote a culture of quality and compliance. This position reports to the Associate Director, Manufacturing and is based out of Newark, CA but may require periodic presence at headquarters in South San Francisco, CA.
Responsibilities include, but are not limited to:
- Enable the successful technology transfer, startup, and operation of the GMP facility, partnering with Quality, Process Development, Engineering and/or IT.
- Lead and/or assist cross functional teams to develop manufacturing batch records, recipes, workflows, and standard operating procedures, ensuring that operational data, configurations, processes, and reports meet all regulatory requirements.
- Manage and approve deviations, non-conformances, change controls and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
- Lead and/or assist investigations as appropriate.
- Support strategy for manufacturing documentation, including standard content and structure for batch records, standard operating procedures, forms, and logbooks.
- Ensure data integrity of various shop floor electronic systems.
- Author, review, own system related documentation.
- Support development of training materials and training of manufacturing staff
- Create and maintain a culture of continuous improvement and operational excellence
- Providing on and off-hour support to manufacturing.
- Collaborate with internal business partners on priorities, timelines and transparent sharing of information.
- Other duties as assigned
Position Requirements & Experience:
- 4 to 6 years of relevant experience with an MS degree or 6 to 8 years of relevant experience with a BS/BA or 10+ years relevant experience with an AS degree. Degree in biological sciences or engineering field strongly preferred.
- Experience in biologics and/or cell therapy GMP manufacturing or process development is required.
- Experience in manufacturing unit operations such as cell culture, aseptic processing, fill/finish preferred.
- Experience working in a regulated environment and be familiar with GMP quality systems/process such as deviations, non-conformances, change controls and CAPAs preferred.
- Demonstrable ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment
- Excellent communication, technical writing, and project management skills.
- Experience with process equipment and process automation systems.
- Understanding of ERP, LIMS, data historian, and other common manufacturing-related IT Systems.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Self-motivated with a strong sense of ownership in areas of responsibility.
- Ability to adapt in a constantly evolving environment.
- 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.