Cellares
Accelerating Access to Life-Saving Cell Therapies
biotech • biotechnology • cell therapy • manufacturing • software
51 - 200
Director, CMC MSAT
July 24
🏢 In-office - San Francisco
Cellares
Accelerating Access to Life-Saving Cell Therapies
biotech • biotechnology • cell therapy • manufacturing • software
51 - 200
Description
• Lead, direct, coach, and develop a team supporting clinical production within a state-of-the art multi-product cell therapy manufacturing facility. Develop team to serve as process and analytical SMEs for internal and external collaborators • Provide technical leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely manner • Provide technical leadership for the design, construction, commissioning, qualification, validation, and operation of a multi-product cell therapy manufacturing facility. Drive facility toward GMP readiness • Lead life cycle management activities related to drug products and GMP manufacturing systems within the facility • Lead and support the development of CMC regulatory filing strategies that anticipate and meet the requirements of global health authorities for cell therapy assets • Own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations and develop appropriate project and departmental metrics • Build and maintain systems to continuously monitor, analyze, and optimize process performance and support and own Quality events, including change controls, investigations, and CAPAs • Oversee the hiring, development, and performance management of staff within the CMC MSAT team • Lead and actively participate in all regulatory and internal audits of the facility • Maintain and understanding of current industry trends and regulatory standards and participate in industry best practice forums • Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site • Establish key stakeholder relationships with internal and external stakeholders
Requirements
• Bachelor's Degree in science, engineering, or related field required • 8+ years of experience within a cGMP environment in the biotech/biopharma industry concentrated within MS&T, Technical Operations, or Technical Development • 6+ years leadership experience. Cell/Gene Therapy and CDMO experience preferred • cGMP manufacturing experience, preferably cell/gene therapy, with experience in tech transfer, process validation, project management, and change management • Expert knowledge of global cell therapy regulations with a deep knowledge of facility/clean room design, process, equipment, automation, and validation • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities • Experience leading regulatory inspections • Experience leading analytical transfer in cell therapy or related field • Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment • Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members • History of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning • Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability • Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization • Experience with Operational Excellence and/or Lean Manufacturing, Green belt or Black belt a plus • Excellent organizational and communication skills • Self motivated and passionate about advancing the field of cell therapy • Self awareness, integrity, authenticity, and a growth mindset
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