Director, Process Development

Prokidney is seeking a highly experienced scientific team leader- Director of Cell Therapy Process Development. This is an exciting and highly visible role for a well qualified and motivated professional.  The successful candidate will play a critical role in providing scientific and operational leadership to support the development and optimization of a robust commercial manufacturing process for a cell therapy product which is in phase III trial. Utilizing sound scientific principles, the Director will support the development of program strategy and lead activities for manufacturing processes development, identification of critical process parameters, technical transfers, validation, and preparation of regulatory filing documents.  A key aspect of the role is building strong collaborations with customers and stakeholders to gather inputs on new processes and provide support to technology transfer and manufacturing. It is important for this leader to develop a diverse and inclusive culture and prioritize career development of team members.

Key Responsibilities

• Direct the development of processes for manufacturing of Prokidney’s cell therapy product. Ensure processes are robust and reproducible. Lead technology transfer activities between development and manufacturing.
• Spearhead process optimization initiatives to increase productivity, improve yield, and maintain product quality. Implement state-of-the-art techniques in manufacturing.
• Lead the execution of process validation and qualification studies, ensuring that the final process meets regulatory requirements and quality standards. Develop and implement control strategies for critical process parameters (CPPs), ensuring optimal process performance and product quality.
• Build and lead a high-performing team of scientists, engineers, and technical experts responsible for process development activities. Foster collaboration across PD, manufacturing, quality, regulatory, and clinical teams to ensure seamless execution.
• Provide mentorship and career development opportunities for team members. Encourage a culture of continuous learning and innovation while managing team performance.
• Lead the preparation of technical documentation for regulatory submissions (INDs, BLAs, etc.), ensuring compliance with regulatory requirements and that process development data supports regulatory filings.
• Identify and assess technical, operational, and regulatory risks associated with process development. Develop and implement risk mitigation strategies to proactively address potential issues.
• Collaborate with senior leadership to define strategic goals for process development, setting clear milestones, timelines. Align departmental objectives with broader organizational goals and prioritize resources accordingly.
• Establish and monitor key performance indicators (KPIs) to assess process performance and team productivity. Regularly report progress to senior management, providing data-driven insights and recommending corrective actions when necessary.

Qualifications

• PhD in Biochemistry, Chemical Engineering, Biotechnology, or a related field. MS or equivalent with extensive relevant experience may also be considered.
• A minimum of 12 years of industry experience in bioprocess development, with at least 8 years in a leadership role within a biopharmaceutical company. Cell therapy experience preferred.
• Extensive experience in cell culture or cell therapy manufacturing. Knowledge of bioprocess modeling, data analysis, and automation. Familiar with process FMEA, QbD, DoE, and statistical analysis tools (JMP).
• Deep understanding of FDA, EMA, and ICH guidelines for biologics and/or cell therapy development. Experience with IND and BLA submissions.
• Knowledge of analytical methods (e.g., flow cytometry, ELISA, biological activity or potency of cellular products) to support process development and release testing.
• Strong project management skills, with experience in managing multiple concurrent projects, resource planning, and budget oversight.
• Excellent leadership, people management, and team-building skills with the ability to inspire, coach, and lead cross-functional teams in a fast-paced environment.
• Exceptional verbal and written communication skills, with the ability to present complex technical information to both technical and non-technical stakeholders.
• Demonstrated ability to apply critical thinking and technical expertise to solve complex process development challenges.
• Strong ability to work collaboratively across teams, departments, and external partners to achieve common goals.

Preferred Qualifications

• Experience working with cell-based therapeutics or personalized medicine.
• Familiarity with process control systems, data analytics, and automation tools for process monitoring and optimization.
• Experience with global regulatory filings, including the preparation of CMC sections of regulatory submissions.
• Experience in a dynamic, high-growth, or start-up environment, with the ability to drive innovation and process development in the face of evolving challenges.