Responsibilities

• Lead, direct, coach, and develop an effective Operations team responsible for daily clinical and production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirements
• Provide technical and managerial 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
• Develop monitor, and improve production metrics related to Safety, Quality, Compliance, Cost, Delivery, and People
• Oversee the hiring, development, and performance management of staff within operations
• Lead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations
• Lead and actively participate in all health authority, customer, and internal audits of the facility
• Serve as the Manufacturing Facility Host for audits by leading tours and serving as SME for the facility
• 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
• Drive site cGMP readiness and work cross functionally to ensure timelines are met; become responsible for maintaining cGMP compliance
• Oversee successful technology transfer from PD; play an active role in the development of the change control strategy, operational readiness, and operator training
• Supply review in S&OP

Requirements

• Bachelor’s degree in science, engineering, or related field required
• A minimum of 12+ years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years leadership experience. Cell/Gene Therapy experience required, CDMO experience preferred
• Previous experience interacting directly with the FDA and other regulatory agencies. Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards
• Demonstrated experience in managing and scaling manufacturing operations
• Demonstrated startup experience or leading organizations through dramatic growth
• 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
• cGMP manufacturing experience, cell/gene therapy, with experience in tech transfer, process validation, project management, and change management
• Experience with Operational Excellence and/or Lean Manufacturing. Lean Six Sigma certification preferred
• Excellent organizational and communication skills
• Self-motivated and passionate about advancing the field of cell therapy
• Self-awareness integrity, authenticity, and a growth mindset