Henk Smit Email & Phone Number

Hoofddorp, North Holland, Netherlands

Amsterdam En Omgeving, Nederland

Leiden, Provincie Zuid-Holland, Nederland

Amsterdam Area, Netherlands

• Management of process development department consisting of 15 employees responsible for early and late stage development, technology transfers and implementation of manufacturing processes to produce AAV-based products.
• For two products in late stage development phase, fulfilling a project lead role in identifying activities, planning and monitoring of progress
• Ensuring to provide technical support to the manufacturing department by performing product impact assessments, process performance evaluations and root cause investigations in support of deviations.
• Ensuring to provide support for all regulatory documentation needed for submissions
• Translating company strategy and objectives into departmental objectives and associated activities
• Responsible for the performance and further development of staff, performance appraisals and recruitment of new hires

Amsterdam Area, Netherlands

• Management of production department consisting of 14 employees focused on downstream production of recombinant proteins, polysaccharides and bio-therapeutic products under cGMP conditions for commercial and clinical.
• Management of four executives focused on the generation and delivery of GMP batch documentation, production deviations, change controls, corrective and preventive actions, audit responses, facilitating training and the.
• Monitor compliance with GMP, laws and regulations, quality, safety, health and safety and environmental guidelines with respect to all procedures within the downstream production department.
• Responsible for the optimal use and control of production materials and production equipment in order to ensure continuity, reliability and safety within the downstream production department.
• Responsible for the quality and timely delivery of the downstream production batches with the corresponding GMP batch quality documentation and records in order to be able to release the batches produced.
• Responsible for recruiting of personnel within the production department and ensuring that the staff gets the required coaching and training.

Amsterdam Area, Netherlands

• Project manager of the technology transfer, development, implementation and validation of a biopharmaceutical production process and analytical methods for phase III clinical production of a vaccine.
• Project manager of the phase I clinical production of lactic acid bacteria.
• Responsible for achieving project objectives within set timelines and budget.
• Daily management of an internal professional multidisciplinary team.
• Active customer relationship management with external customers and partners.

Leiden, The Netherlands

• Project leader at the implementation and process validation of a new cell retention system and filter in a commercial fermentation process for the production of a monoclonal antibody.
• Technical Integrator of a fermentation and purification process for the production of a commercial monoclonal antibody responsible for the technical support, validation, development and implementation of the production.
• Chairman at weekly departmental Process Development meeting.
• Primary upstream contact at regulatory inspections.
• Coordination of work within the department.
• Perform Root Cause investigations and impact assessments to close out process related deviations.

Leiden, The Netherlands

• Responsible for initiating and leading projects and initiatives focused on the development and implementation of purification (sub-) processes in support of the production of (new) monoclonal antibodies at production.
• Team leader at the technology transfer and implementation of a phase III purification process from R&D (US) to the production plant (Leiden).
• Team leader at the production of phase III clinical batches and validation downstream batches in the production plant.
• Active participation in the generation of a license application in support of the commercialisation of a new monoclonal antibody.
• Active participation in pre-approval inspections undertaken by different health authorities (e.g. the EMEA and the FDA) in support of the commercialisation of a new monoclonal antibody.
• Team leader at the technology transfer and implementation of a commercial purification process from R&D (US) to the production plant (Leiden).

Leiden, The Netherlands

Management of a department consisting of four process developers / engineers focused on providing technical support, the facilitation of technology transfers and the execution of process validation in support of the downstream production of (new) monoclonal antibodies at production scale.

Leiden, The Netherlands

• Responsible for executing and leading projects and initiatives focused on the improvement of existing or implementation of new purification (sub-) processes in support of the production of monoclonal antibodies at.
• Project manager of a technology transfer project from R&D (US) to the production plant (Leiden) for the production of a new monoclonal antibody in support of phase III clinical studies.
• Project manager of an implementation project of an up-scaled chromatography and ultra-filtration process in de production plant.
• Process development for and production of a new monoclonal antibody in support of phase 0 clinical studies.
• Supervision of a trainee focused on optimisation of a new chromatography process.

Leiden, The Netherlands

• Responsible for executing projects and initiatives focused on the improvement of existing purification (sub-) processes in support of the production of monoclonal antibodies at production scale:
• Process optimisation of a commercial downstream process by initiating and executing chromatography, ultra-filtration and filtration experiments at laboratory and pilot-scale.
• Supervisor at the execution of the first production batches in a new production facility in a temporary 24/7 shift schedule.
• Active participation in the commissioning and validation of new process equipment in a new production facility.

Delft Area, Netherlands

Metabolic research into the penicillin biosynthesis in a fungus by executing continuous cultures and fed-batch fermentation runs at laboratory scale.

Master Of Technological Design (Mtd), Bioprocess Engineering

• One-year graduation project in process design at DSM Research in Geleen, the Netherlands. • Project leader in a process design for the.

Master’S Degree, Chemical Engineering

Activities and Societies: Student member in Counsil of Chemical Faculty Vice-president of student organisation ACD • Graduation project in.