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Senior Operations Manager
2 months ago
VALID8 Financial is seeking a Senior Operations Manager to oversee CAR-T cell therapy manufacturing processes.
This pivotal role will report directly to the head of Technical Operations and will be responsible for managing the daily clinical manufacturing activities of CAR-T cell products.
The successful candidate will lead the manufacturing team, ensuring compliance with Good Manufacturing Practices (GMP) and facilitating various initiatives aimed at enhancing quality and operational efficiency.
Key Responsibilities:
- Direct the manufacturing team in planning and executing CAR-T cell therapy productions to fulfill clinical requirements.
- Collaborate closely with cross-functional teams to ensure effective technology transfers.
- Oversee cleaning staff and contractors to maintain manufacturing areas in accordance with established standard operating procedures (SOPs).
- Foster strong collaborations with Quality Assurance, Supply Chain, and other relevant departments.
- Promote a culture of safety within the workplace, ensuring compliance with company policies and regulatory requirements.
- Set performance goals, track key performance indicators (KPIs), and drive continuous improvement initiatives.
- Establish a robust manufacturing management system that ensures operational efficiency and compliance with GMP standards.
- Organize schedules for personnel, facilities, equipment, and materials to support CAR-T manufacturing capacity.
- Identify and mitigate risks in manufacturing operations to ensure the delivery of safe and effective therapies.
- Lead investigations related to manufacturing processes, ensuring timely resolution of deviations and corrective actions.
- Develop and implement internal training programs to enhance team productivity and compliance.
- Draft, review, and approve various GMP documentation, including SOPs and batch records.
Qualifications:
Applicants should possess a Bachelor's or advanced degree in a relevant scientific or engineering discipline. A minimum of 7 years of experience in cGMP biologics manufacturing or cell therapy operations is required, including at least 3 years in a managerial capacity. Familiarity with Lean Manufacturing principles and experience in supporting commercial licensure of CAR-T or similar products is preferred.
In-depth knowledge of CAR-T manufacturing processes, including cell culture and aseptic processing, is essential. Candidates should have a strong background in training and GMP compliance, as well as experience in managing and directing manufacturing staff in a biopharmaceutical setting.
