We are recruiting a talented and experienced Director of Manufacturing Operations to help build our GMP manufacturing organization. This individual will be a key member of the manufacturing site senior leadership team, and will work closely with Lyell Tech Operations leadership to develop and grow the manufacturing operations, including establishment of the infrastructure, hiring and training members of the team, and assisting in the commissioning and readiness of a new cGMP clinical manufacturing site producing both viral vectors and autologous cell therapies. The successful candidate will have experience with cell and gene therapy manufacturing activities, experience with CMC project timelines and activities, experience in preparing and managing annual operating plans and budgets for GMP facilities, and a thorough understanding of the technological requirements for cell therapy manufacturing operations.
- Build Facility and Operations
- Serve on the Lyell GMP Facility Project Team as the Manufacturing representative.
- Work collaboratively with the Directors/Leads from Engineering, Quality, Process Sciences and Vector Sciences on all aspects of facility design, construction, qualification and start-up.
- Play critical leadership role in the development of the operating paradigm for Manufacturing Operations; this role is responsible for developing and establishing how Lyell will run all aspects of GMP Cell Therapy Manufacturing operations.
- Direct the Day-to-Day Manufacturing Operations
- Lead the development and implementation of GMP procedures and policies related to Manufacturing Operations.
- Establish robust operations and scheduling systems that maximize use of facility and staff and ensure on time delivery of treatment to patients.
- Ensure that production facilities are maintained at a high standard of cleanliness and organization, equipment maintenance and calibrations are performed, and GMP documentation is completed and reviewed in a timely manner.
- Ensure all staff maintain appropriate level of training.
- Develop and effectively manage department annual operating budgets for Lyell Manufacturing Operations.
- Work with key stakeholders to develop execution plans for increasing capacity and throughput of operations.
- Identify and mitigate risks in manufacturing operations that could negatively impact the quality of patient therapies.
- Provide Leadership
- Provide exceptional leadership skills to the organization including hiring, mentoring and developing staff.
- Use strong communication and teamwork skills to build strong relationships with stakeholders.
- Demonstrate outstanding technical acumen, operational understanding and GMP compliance in building and running the Manufacturing Operations Department.
- Champion operational excellence initiatives, and the implementation of new technologies and systems.
- Ensure a culture of strong GMP compliance.
- Establish a progressive culture of World Class GMP Manufacturing Operations.
- 10+ years of experience years of experience in cGMP biopharmaceutical manufacturing operations including 5+ years in cell and gene therapy operations.
- 10+ years of experience managing people in technical GMP roles.
- Experience in senior technical roles within a GMP biopharmaceutical manufacturing operation, experience working in process development is a plus.
- Working knowledge of USA and global regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, including requirements for clinical phase appropriate validation/qualification.
- Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
- Experience in technology transfer (e.g., from academic institutions or to a third-party contract manufacturing organization (CMO)) and implementation of new technologies in a regulated environment (e.g., GMP, GLP, GxP)
- Prior experience in either design, qualification, start-up of manufacturing facilities preferred
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