For our global Technical Operations Organization, we are currently looking for a
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.
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)
Scale-Up & Technology Transfer
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
Scientific & Technical Strategy
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
Regulatory & Compliance
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
Cross-Functional Collaboration
Partner with MS&T, Manufacturing, Analytical Development, Quality, and Regulatory teams
Align process strategies with product and portfolio goals
Leadership & Organizational Development
Lead and mentor multidisciplinary teams (scientists, engineers)
Manage budgets, resources, and project priorities
Build a high-performing, innovative team culture
Lifecycle Management & Continuous Improvement
Support process validation and continued process verification (CPV)
Drive process optimization using data analytics and statistical tools (DOE, multivariate analysis)
Implement improvements post-commercialization
Your experience
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
Key Skills
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
Are you interested? We are looking forward to receiving your online application.
