- 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.
- Collaborate with cross-functional teams to troubleshoot manufacturing issues and implement solutions.
- Providing on and off-hour support to manufacturing.
- 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.
- Collaborate with internal business partners on priorities, timelines and transparent sharing of information.
- Create and maintain a culture of continuous improvement and operational excellence.
- Stay informed about advances in cell therapy manufacturing technologies and industry best practices.
- Other duties as assigned
- Bachelor's or Master's Degree in Biological Sciences, Chemical Engineering, or a related field strongly preferred.
- Relevant industry experience with knowledge of cell culture techniques, aseptic processing, and GMP regulations
- Experience working in a regulated environment and be familiar with GMP quality systems/process such as deviations, non-conformances, change controls and CAPAs preferred.
- Experience with cell processing equipment and process automation systems preferred.
- Demonstrable ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment.
- Strong analytical and problem-solving skills, with the ability to troubleshoot technical issues independently.
- 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.
- 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. We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $100,000 to $130,000. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. As an equal opportunity employer, Allogene 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients. #LI-EL1
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Engineer, Manufacturing Science and Technology - Newark, United States - Allogene
1 week ago
Description
About Allogene:
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 TTM) products for cancer and autoimmune disease.
Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product 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 , and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.About the role:
Allogene is seeking a Manufacturing Sciences and Technology (MSAT) Engineer 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 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:
Position Requirements & Experience:
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