Director, Process Development

For our global Technical Operations Organization, we are currently looking for a

Director, Process Development

The Director of Process Development leads the design, development, and scale-up of bioprocesses for biologics manufacturing. This role provides strategic and technical leadership to ensure robust, scalable, and compliant upstream and downstream processes across the product lifecycle, from early development to commercial production.

Key Responsibilities:

Bioprocess Development Leadership

• Lead development of Albumin downstream (purification) processes
  
• Define process strategies to optimize yield, quality, and scalability
  
• Establish critical process parameters (CPPs) and critical quality attributes (CQAs)
  

• Oversee scale-up from lab to pilot and commercial manufacturing
  
• Lead technology transfer to manufacturing sites and external partners (CMOs/CDMOs)
  
• Ensure process consistency and robustness across scales and sites
  

• Provide expertise in biologics production systems (e.g., CHO, microbial systems, viral vectors)
  
• Drive innovation and adoption of new bioprocessing technologies
  
• Lead troubleshooting and resolution of complex process challenges
  

• Ensure compliance with GMP and global regulatory expectations
  
• Support regulatory submissions (IND, BLA/MAA) with process development data
  
• Act as SME during inspections and audits
  

• Partner with MS&T, Manufacturing, Analytical Development, Quality, and Regulatory teams
  
• Align process strategies with product and portfolio goals
  

• Lead and mentor multidisciplinary teams (scientists, engineers)
  
• Manage budgets, resources, and project priorities
  
• Build a high-performing, innovative team culture

• Support process validation and continued process verification (CPV)
  
• Drive process optimization using data analytics and statistical tools (DOE, multivariate analysis)
  
• Implement improvements post-commercialization
  

• PhD (preferred) or Master's in Biotechnology, Biochemical/Chemical Engineering, or related field
  
• 12-18+ years of experience in bioprocess or biologics development
  
• Strong expertise in downstream processing
  
• Proven experience in scale-up, tech transfer, and commercial manufacturing support
  
• Deep understanding of GMP and regulatory frameworks (FDA, EMA)
  
• Demonstrated leadership and team management experience
  
• Understanding plasma process development preferable
  

• Deep technical expertise in bioprocessing
  
• Strategic leadership and decision-making
  
• Strong problem-solving and analytical skills
  
• Cross-functional collaboration and stakeholder management
  
• Innovation and continuous improvement mindset