Director, Process Development

Director of Cell Therapy Process Development

This is a senior leadership role for an experienced scientific professional who will provide strategic and operational oversight for the development and optimization of a commercial manufacturing process for a Phase III cell therapy product. The position involves guiding program strategy, leading process development activities, identifying critical process parameters, managing technology transfers, overseeing validation, and preparing regulatory documentation. A key focus is fostering collaboration with internal and external stakeholders and building an inclusive, high-performing team.

Key Responsibilities

• Direct the development of robust, reproducible manufacturing processes for cell therapy products.
• Lead technology transfer activities between development and manufacturing teams.
• Drive process optimization initiatives to improve productivity, yield, and product quality using advanced techniques.
• Oversee execution of process validation and qualification studies to ensure compliance with regulatory standards.
• Develop and implement control strategies for critical process parameters (CPPs).
• Build and lead a team of scientists, engineers, and technical experts; promote collaboration across process development, manufacturing, quality, regulatory, and clinical functions.
• Provide mentorship and career development opportunities; foster a culture of innovation and continuous learning.
• Prepare technical documentation for regulatory submissions (INDs, BLAs, etc.) ensuring compliance and data integrity.
• Identify and mitigate technical, operational, and regulatory risks.
• Collaborate with senior leadership to define strategic goals, set milestones, and allocate resources effectively.
• Establish and monitor KPIs for process performance and team productivity; report progress and recommend corrective actions.

Qualifications

• PhD in Biochemistry, Chemical Engineering, Biotechnology, or related field (MS with extensive experience may be considered).
• Minimum 12 years of industry experience in bio process development, including 8+ years in leadership roles.
• Strong background in cell culture or cell therapy manufacturing.
• Expertise in bio process modeling, data analysis, and automation; familiarity with FMEA, QbD, DoE, and statistical tools (e.g., JMP).
• In-depth knowledge of FDA, EMA, and ICH guidelines for biologics/cell therapy development; experience with IND and BLA submissions.
• Understanding of analytical methods such as flow cytometry, ELISA, and potency assays.
• Proven project management skills, including multi-project oversight, resource planning, and budgeting.
• Exceptional leadership and team-building abilities; strong communication skills for technical and non-technical audiences.
• Demonstrated problem-solving and critical thinking capabilities.

Preferred Qualifications

• Experience with cell-based therapeutics or personalized medicine.
• Familiarity with process control systems, data analytics, and automation tools.
• Experience preparing CMC sections for global regulatory filings.
• Background in dynamic, high-growth, or start-up environments with a focus on innovation.

Additional Requirements

• Must be eligible to work in the United States without sponsorship.
• Commitment to diversity, equity, and inclusion.