Director of Process and Manufacturing Science

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.

Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work related resources.

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short term disability.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you.

Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities.

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