POSITION SUMMARY:

You will be responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role will work closely with the Process Sciences, Vector Sciences, and Manufacturing Sciences and Technology (MSAT) teams to transfer and execute clinical manufacturing processes, and establish procedures for equipment and manufacturing operations. 

KEY ROLE AND RESPONSIBILITIES:

Startup Facility and Operations

• Work collaboratively with the MSAT, Quality, Process Sciences and Vector Sciences on all aspects of facility qualification and start-up.
• Support the development of the operating paradigm for GMP cell therapy and viral vector manufacturing operations.

Execute the Day-to-Day Manufacturing Processing

• Assist in development and implementation of GMP procedures and policies 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 and calibrations as required, and complete and review GMP documentation in a timely manner.
• Maintain appropriate level of training for assigned responsibilities.
• Work with TechOps teams to execute technology transfers and capacity building projects.
• Identify and mitigate risks in the manufacturing areas that could negatively impact the quality of patient therapies.

Collaborate Effectively

• Use strong communication and teamwork skills to build relationships across the manufacturing site.
• Demonstrate technical acumen, operational understanding, and GMP compliance in managing the manufacturing operations.
• Support operational excellence initiatives, and the implementation of new technologies and systems.
• Ensure a strong culture in safety and GMP compliance

PREFERRED EDUCATION:

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

PREFERRED EXPERIENCE:

• 0 - 2 years of 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).

KNOWLEDGE, SKILLS AND ABILITIES:

• 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.

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 $31.25 to $36.06 hourly, 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. More information on our extensive benefits offering can be found on our website.