Director, CMC MSAT

We are seeking a highly motivated Director of CMC MSAT who will be responsible for supporting the launch, ramp-up, and production activities within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.

This individual will partner with other functions to support the production of cell therapy products through safe and compliant manufacturing operations according to cGMP requirements. This individual will oversee process engineering, manufacturing support, technology transfer, qualification, validation, and cell therapy automation and provide technical and continuous improvement support to ensure robust production, testing, and the timely release of cost-effective, compliant, and high-quality cell therapy products.

As such, the role will require proven leadership to drive effective problem solving, communication, coordination, and collaboration across relevant cross functional groups. The role will be responsible for all process and analytical transfer and support needs. This is a multidisciplinary role and this individual will need the ability to interface with all levels of the organization, including Manufacturing, QA, QC, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, Commercial, Program Management, HS&E, and Finance.

The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

• 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