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Director of Process and Manufacturing Science
2 months ago
Director of Process and Manufacturing Science
Kelly® Science & Clinical is seeking a Director of CMC MSAT for a direct-hire position at a cutting-edge cell therapy manufacturing client in South San Francisco, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Salary: $170k+, depending on experience
Schedule: Standard working hours
Responsibilities:
Provide leadership for the design, construction, commissioning, qualification, validation, and operation of the multi-product cell therapy manufacturing facility, driving GMP readiness.
Lead and support CMC regulatory filing strategies to meet global health authority requirements for cell therapy assets.
Manage the development and performance of the CMC MSAT team, including hiring and coaching staff to serve as process and analytical SMEs for both internal and external collaborations.
Drive continuous improvement initiatives within cell therapy technical operations and take ownership of Quality events, including change controls, investigations, and CAPAs.
Establish and maintain strong collaboration with cross-functional stakeholders to ensure timely production and release of cell therapy products.
Oversee lifecycle management activities related to drug products and GMP manufacturing systems.
Actively participate in regulatory and internal audits, ensuring compliance with industry standards.
Keep abreast of industry trends and regulatory standards and contribute to industry best practice forums.
Develop and execute strategic plans in partnership with other functional areas to support the manufacturing site’s goals and objectives.
Ensure that the team provides technical leadership to successfully manufacture and disposition products to patients.
Qualifications:
Bachelors degree in a relevant scientific or engineering field.
8+ years of experience in a regulated manufacturing environment, particularly in roles focused on technical operations, process engineering, or product development.
Strong background in manufacturing practices, including 6+ years of experience in process optimization, technology transfer, project management, and change management.
Comprehensive understanding of regulatory requirements and facility design for manufacturing operations.
6+ years of leadership experience, with a preference for candidates who have worked in advanced therapy or specialized manufacturing environments.
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