Director, Process Development

ProKidney • Winston-Salem, NC

383d

About The Position

The Director of Process Development at ProKidney is a senior leadership role focused on the development and optimization of commercial manufacturing processes for a cell therapy product aimed at treating chronic kidney disease (CKD). This position involves providing scientific and operational leadership, ensuring robust and reproducible processes, and leading technology transfer activities. The director will also foster collaboration across various teams, mentor staff, and ensure compliance with regulatory requirements while driving innovation in a fast-paced environment.

Requirements

• PhD in Biochemistry, Chemical Engineering, Biotechnology, or a related field.
• A minimum of 12 years of industry experience in bioprocess development, with at least 8 years in a leadership role within a biopharmaceutical company.
• 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.
• Strong project management skills, with experience in managing multiple concurrent projects.

Nice To Haves

• 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.

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 compliance with regulatory requirements and quality standards.
• Develop and implement control strategies for critical process parameters (CPPs).
• 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.
• 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.).
• Identify and assess technical, operational, and regulatory risks associated with process development.
• Develop and implement risk mitigation strategies.
• Collaborate with senior leadership to define strategic goals for process development.
• Establish and monitor key performance indicators (KPIs) to assess process performance and team productivity.

Benefits

• Competitive salary range of $152K - $192K per year.
• Opportunities for career development and mentorship.
• Inclusive work environment that promotes diversity.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree