Manufacturing Supervisor (tech Ops)

Manufacturing Supervisor (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 new cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. The Supervisor lead a team of manufacturing associates responsible for day to day operations. The Supervisor will lead a team of direct reports responsible for all manufacturing operations. The successful candidate will have GMP, industry experience in manufacturing autologous cell therapies, lentiviral vector manufacturing, and/or plasmid production.

KEY ROLE AND RESPONSIBILITIES:

Execute the Day-to-Day Manufacturing Processing:

• Lead daily operations and resolve floor issues.
• Provide routine on-the-floor support and execute operations.
• Ensure all operational duties are completed each day/shift.
• Assist in development and implementation and GMP procedures and programs related to Manufacturing Operations.
• Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
• Maintain production facilities at a high standard of cleanliness and organization.
• Perform equipment maintenance as required.
• Complete and review GMP documentation in a timely manner.
• Maintain training for assigned responsibilities of oneself and team.
• 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, CAPA, and change controls.

Lead a Team:

• Lead a team of direct reports responsible for all aspects of manufacturing operations.
• Demonstrate technical acumen, operational understanding, and GMP compliance.
• Identify opportunities for continuous improvement, demonstrate accountability and ownership, and assist with timely resolution.
• In collaboration with manager, coach and mentor team members for optimal performance.
• Influence team culture, continuous improvement, accountability, learning, compliance, and problem solving.
• Assist with hiring and recruiting.
• Use strong communication and teamwork skills to build relationships.
• Establish and maintain collaborative relationships with site departments.
• Promote a culture of safety and GMP compliance.
• Lead team meetings and huddles.

PREFERRED EDUCATION & EXPERIENCE:

• BSc degree in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field)
• 8+ years of experience in cGMP biopharmaceutical manufacturing operations, preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.
• Experience leading teams within a manufacturing setting.
• Experience driving projects and teams to completion of tasks.
• 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.