Manufacturing Lead Associate (tech Ops)

Manufacturing Lead Associate (Tech Ops)

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 supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is primarily responsible for performing daily manufacturing operations. The role will also be responsible for supporting additional manufacturing responsibilities.

Key Role And Responsibilities

Execute the day-to-day manufacturing processing

• Provide routine on-the-floor support and execute operations.
• Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
• Assist the supervisor leading daily operations and resolving floor issues.
• Assist the supervisor to ensure all operational duties are completed each day/shift.
• Assist in development and implementation of GMP SOPs related to Manufacturing Operations.
• Maintain production facilities at a high standard of cleanliness and organization.
• Perform equipment maintenance and calibrations as required.
• Maintain appropriate level of training for assigned responsibilities.
• Identify and report risks in the manufacturing areas that could negatively impact the quality of patient therapies.
• Ensure timely review and closure of electronic batch records, exceptions, deviations.
• Assist with CAPA and change controls as needed.

Collaborate Effectively

• Be a team player, offer assistance, and respond well to requests for help from team members.
• Use strong communication and build relationships.
• Demonstrate technical acumen, operational understanding, and GMP compliance.
• Support operational excellence initiatives.
• Promote a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.
• Lead team huddles.

Preferred Education & Experience

BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field)

Minimum 8 years' experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.

Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).

Experience with electronic systems such as MES and ERP.

Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.

Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.

Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.

The desire and ability to work in a fast-paced, start-up environment.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:

Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.

Stand and step over a gowning bench (12-24") and aseptically don head-to-toe non-sterile and sterile gowns.

Shift Work, Weekend Work And Holiday Coverage

Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.