Do the best work of your life and enjoy it.
You will be responsible for supporting the operations in our new cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. You will lead a team of manufacturing associates responsible for day to day 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 and calibrations 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.
- BSc degree in a relevant field (eg 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.
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.
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 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.