Manufacturing Lead Associate (Tech Ops)

Overview

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 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.
• 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

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 :

Shift Work

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.

Benefits and Equal Opportunity

Lyell offers its employees a range of compensation and benefits. The following information highlights 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 days' 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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