Manufacturing Specialist, MES/Batch Record Design
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 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 Manufacturing Specialist, MES/Batch Record Design who will be responsible for developing and owning the manufacturing document strategy and leading the design and implementation of batch records, manufacturing documentation, and Manufacturing Execution Systems (MES) for our state-of-the-art allogeneic CAR T cell therapy manufacturing facility. The job scope includes implementation of manufacturing documentation, including batch records, logbooks, and Standard Operating Procedures as well as support for implementation of an MES system, including recipe management, materials management, sample management, workflow, user interfaces, instrument integration, integration with ERP systems, etc.
This role will lead and participate in manufacturing batch record recipe design and will be responsible for coordinating activities with Manufacturing, Quality, Engineering and IT ensure successful implementation of batch records. The candidate will provide expertise on document design to achieve clarity and efficiency in the manufacturing operations, while complying with all cGMP regulations. This role will lead design, implementation and operation of the MES systems, including electronic batch records. The candidate will work with manufacturing supervisors to ensure proper training of the automated systems is provided to all manufacturing floor staff. This position is based out of Newark, CA but may require periodic presence at headquarters in South San Francisco, CA.
The successful candidate will have experience in a regulated biotech or pharmaceutical setting and will have proven competency and expertise developing, implementing, supporting and troubleshooting Manufacturing Batch Records / documentation and Manufacturing Execution Systems (MES).
- Develop strategy for manufacturing documentation, including standard content and structure for batch records, standard operating procedures, forms, and logbooks.
- Lead 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.
- As business owner, lead and provide support in the design, development, and qualification of manufacturing execution systems.
- Ensure data integrity of various shop floor electronic systems utilizing MES where appropriate.
- Support the roll out of MES software by creating relevant documentation, end user training and managing user accounts.
- Collaborate with internal business partners on priorities, timelines and transparent sharing of information.
- 2 to 3 years of relevant experience with an MS degree or 3 to 4 years of relevant experience with a BS/BA or 5+ years relevant experience with an AS degree. Degree in biological sciences or engineering field strongly preferred.
- Excellent communication, technical writing, and project management skills.
- Deep Master Batch Record and manufacturing document design expertise demonstrated with formal training and experience.
- Experience in biologics manufacturing unit operations such as cell culture, aseptic processing, fill/finish strongly preferred.
- Demonstrated experience implementing software systems and performing tasks in a regulated or pharmaceutical production environment.
- Core Computer IT Skills and capability to learn advanced IT skills.
- Experience with Process Equipment and Process Automation Systems in MES context
- Thorough understanding of Master Data in MES Context, ability to define and manage master data working with a cross-functional team from Manufacturing, Quality, Engineering, and Supply Chain
- Understanding of ERP, LIMS, data historian, and other common manufacturing-related IT Systems and integration requirements with MES systems is highly preferred.
- Experience working with MES teams to build interfaces for plant equipment.
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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.