Responsibilities

• Lead, direct, coach, and develop an effective CMC Process Sciences team, including CMC Operations, Process/Analytical Development, and MS&T, that will develop phase appropriate processes and procedures required to support our partners through the launch, ramp-up, and production within our state-of-the-art multi-product cell therapy manufacturing facility
• 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
• Provide expert scientific and technical evaluation of complex process and product quality data throughout the product development and product lifecycle to our clients in the adoption of our cell therapy manufacturing technology
• Lead the identification of control strategy development requirements for cell therapy product classes (i.e., QTPP creation, risk assessments, CQA identification, specification setting, potency matrix strategy)
• Drive CMC program milestone achievement with our partners through the adoption of our cell therapy manufacturing technology, including tech transfer, process comparability, process validation, etc.
• Oversee the hiring, development, and performance management of staff within CMC Process Sciences
• Establish critical KPIs, monitor progress and keep critical stakeholders informed of progress
• Actively participate in all regulatory meetings and inspections concerning CMC development plans and strategies and facility inspections
• Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site and our facility network
• Establish key stakeholder relationships with internal and external stakeholders

Requirements

• Ph.D. degree in life sciences or equivalent work experience
• 12+ years of experience within a cGMP environment in the biotech/biopharma industry concentrated in Technical Development or Technical Operations with a minimum of 8 years leadership experience. Cell/Gene Therapy experience required
• Must be an expert within CMC Development with extensive experience with CMC process and analytical strategy and engineered T cells and gene editing technologies
• Significant experience in biologics process development or analytical characterization, especially in Cell Therapy
• Expert knowledge of process characterization and validation with consideration of current regulatory expectations, i.e. quality-by-design approach for biologics and ATMPs
• Significant knowledge of Global Regulatory requirements and standards applicable to ATMPs
• Significant knowledge of Good Manufacturing Practices requirements and experience in CMC-development and manufacturing of pharmaceutical products
• 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 is 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