Leidschendam, South Holland, Netherlands
Accomplished pharmaceutical and biotechnology professional with 20+ years in Drug Product Development and MSAT. Experienced across small molecules, biotech drug products, and CAR-T (Cell Therapies). Proven in technology transfer, scale-up, process validation, deviation management, quality investigation and sterility assurance. At Bristol Myers Squibb, I built and led a BSL-2/ML-I MSAT laboratory, enabling the concurrent manufacturing of CAR-T batches and training activities, all aimed at reducing the readiness delay for PPQ batches by 6 months. Previously at Dompé, I led late-phase process development and validation across multiple dosage forms, collaborating with CDMOs to manage process improvement and address quality deviations associated with commercial products. Known for translating R&D into robust, compliant manufacturing, aligning internal teams and CMOs, and driving lean improvements. Skilled in DOE, QbD, statistical analysis, and regulatory compliance.
• Built and led MSAT laboratory (BSL-2/ML-I), reducing the readiness delay for PPQ batches by 6 months. • Managed Aseptic Process Simulation (APS) for CAR-T clinical manufacturing (Annex 1). • Re-established lab capacity to support up six simultaneous manufacturing and training operations. • Directed strategy for cost reduction that integrates a minimal capital expenditure (CAPEX) investment along with the utilization of external laboratory service operations. • Oversaw root cause analyses and deviation management for CAR-T.
• Led industrialization, scale-up, and validation for solid and liquid (oral), semi-solid (topical), sterile lyophilized (parenteral) and biotech liquid (ophthalmic). • Increased batch size with new fluid-bed granulator for taste-masked granules. • Validated new packaging for oral drops (AQL visual inspection). • Directed late-phase process development and scale-up of NCE tablet manufacturing. • Coordinated CDMO partnerships for large-scale technology transfer.
• Supervised 3 scientists and 2 technicians in formulation and analytical development. • Managed NCE drug product development across all clinical phases (I–III). • Enhanced commercial formulations to improve patient compliance. • Directed tech scouting projects for innovative formulation approaches. • Supported budgeting and regulatory documentation.
• Designed and executed formulation/process development for oral solids from early-stage (preformulation) through all clinical phases. • Led technology transfer and scale-up for commercial production. • Conducted stability studies and excipient compatibility testing. • Cross-functional team collaboration to optimize products design and transition from R&D to manufacturing.
- Formulation and process development studies of topical and dermatological products (emulsions, ointments, gels, drug delivery systems) and pulmonary delivery (sterile inhaled solutions and suspensions). - Devised and performed lab. scale experiments within internal facility. - Scouting and evaluation of novel oral, parenteral, and pulmonary drug delivery systems.
- Formulation development studies of pulmonary delivery (sterile inhaled solutions and suspensions), oral granules and topical and dermatological products (emulsions, ointments, gels, drug delivery systems). - Devised and performed lab. scale experiments within internal facility.