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Specialist, Manufacturing Execution System

South San Francisco, California, United States
Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response.  We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.
 
Position Summary:

The individual in this role will be responsible for implementing and supporting the Manufacturing Execution System (MES) and electronic Master Batch Records (MBRs) strategy. This role provides MES system support to Manufacturing, MSAT, Technical Transfer, Quality and Supply Chain to ensure priorities are being addressed in a timely manner to meet the company’s clinical programs timeline.

Key Role and Responsibilities:

  • Continue to advance strategy for manufacturing documentation, including standard content and structure for batch records, standard operating procedures, forms, and
  • 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.
  • Support the system owner to 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
  • 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.
  • Design, implement, and test MES based on the Business process
  • Provide MES support for production that includes hours outside of normal business
  • Implement and maintain LIMS interactions and calculations, QMS for deviation generation during the process, and interface with ERP system to issue materials to MBRs that are acceptable & released.
  • Support the development and optimization of manufacturing
  • Configure/update MES to support new clinical programs and change
  • Coordinate the review and revisions of procedures, Process Development/Technical Transfer documentation and FDA regulations for inclusion in SOP and quality
  • Responsible for ensuring compliance with Federal, State and local regulations and alignment to company policies and procedures relating to GMP's, Health, Safety & Environmental Protection.

Preferred Education:

  • BA/BSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 5 years’ experience; or
  • MBA or MSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 3 years’ experience
PREFERRED EXPERIENCE:
  • Minimum 2 years’ experience in GMP manufacturing and operations experience with emphasis on MES deployment.
  • Experience in Manufacturing Execution Systems primarily in having designed and created best practice MBRs.
  • Experience with Process Equipment and Process Automation Systems in MES context. Ability to support interfaces builds for plant equipment.
  • Experience in cell therapy or biologics manufacturing unit operations such as cell processing, aseptic processing, fill/finish.
  • Demonstrated experience implementing software systems and performing tasks in a regulated or pharmaceutical production environment.
  • Excellent communication, technical writing, and project management
  • Deep Master Batch Record and manufacturing document design expertise demonstrated with formal training and experience.
  • Core Computer IT Skills and capability to learn advanced IT
  • Thorough understanding of Master Data in MES Context, ability to define and manage master data working with a cross-functional team from Manufacturing, Quality, 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
Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.
 
The salary range for this position is $108,000 to $120,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.
 
Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, 9 day’s sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. 
 
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
 
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.

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