Director, Process DevelopmentWinston-Salem, North Carolina, United States (Winston-Salem)

Director, Process Development

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.

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

Preferred Qualifications

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.