Bernard Jacques

Leading Development, Pre-Clinical and Commercial Viral Vector manufacturing facility in Gosselies and Seneffe (Belgium) and play a key role in growing the business as a leader in the Gene Therapy Contract Manufacturing market.

Heading the operation department of the BioPharma BU including manufacturing units, QC, supply chain and product transfer development, both for biologics (plasmids and proteins) and mRNA.

Exothera is a Belgium-based CDMO delivering customized process development and GMP manufacturing services for gene therapy and viral vector-based vaccines. As a Univercells company, Exothera capitalizes on novel manufacturing technologies and best-in-class bioprocessing expertise to provide bespoke process optimization and GMP clinical and commercial production of viral vectors.

Responsible for all aspects of Safety, Quality, Cost for aseptic operations of bulk manufacturing of Hepatitis A vaccines from cell culture to final inactivation. Activities driven by the highest productivity and flexibility, so as to cope with demand, cost and security, including sustainability (validation, troubleshooting, EMAP, Product Exp.), project, planning and facility and equipment aspects (maintenance). Strong EHS orientation with specific focus on “Living Safety” initiatives and Gemba on shopfloor. Regular frontline contact for regulatory inspections for a vast range of markets (including US, Japan, China, Belgium) Current focus on Quality improvements to ensure compliance with cGMP requirements together with training initiatives to ensure all employees fully understand these requirements

Responsible for all aspects of Safety, Quality, Cost for aseptic operations including formulation, filling and visual inspection of the Rotavirus vaccine with the highest quality standards. Activities driven by the highest productivity and flexibility, so as to cope with demand, cost and security, including sustainability (validation, troubleshooting, EMAP, Product Exp.), project, planning and facility and equipment aspects (maintenance). Strong EHS orientation with specific focus on “Living Safety” initiatives and Gemba on shopfloor. Regular frontline contact for regulatory inspections for a vast range of markets (including US, Japan, China, Belgium) Current focus on Quality improvements to ensure compliance with cGMP requirements together with training initiatives to ensure all employees fully understand these requirements

Responsible for all aspects of Safety, Quality, Cost for aseptic operations including formulation, filling, lyophilization and visual inspection with the highest quality standards. Inspections for a vast range of markets (including US, Japan, China, Belgium) Current focus on Quality improvements to ensure compliance with cGMP requirements together with training initiatives to ensure all employees fully understand these requirements Recognized aseptic expert with auditing qualifications and coaching partner for production and quality personnel Member of the Social Governance Bodies with major interactions with Social Partners and Unions. Active contribution in the legal collective contracts negociations with blue collars and white collars unions.

Manage extensive green field and revamping projects as process owner, Clean rooms and Aseptic engineer (Capital Investment Projects with more than 400 M€ budget) Manufacturing Representative and Process Owner in all GSK Bio Secondary projects (existing facility upgrades and new facilities) in Europe and USA with the successful starting of two new GSK Vaccines Manufacturing units in France and USA. Delivering expertise on Way of Working in the following technologies : syringes and vials filling line (RABS and isolators), visual inspection machines, stoppers processors, freeze-dryers, formulation isolator and RABS and general aseptic practises. Co-ordinate validation activities in order to guarantee the initial qualification and the maintaining of validation status for processes, machines and equipment, systems, instruments and computer systems. Co-ordinate and review technical regulatory file submission for revamping and new facilities projects.

Manufacturing Manager of a filling unit (3 filling lines and 5 freeze-dryers) with annual output of 25 millions of freeze-dryed vaccines doses. Managing day-to-day vaccines operations so as to cope to the demand. Manage a team of supervisors and their related staff (110 people). Frontline inspection management (e.g. FDA, Ministry of Health, WHO, Due diligence, Environmental and Quality System audits). Production scheduling optimising the use of filling lines and resources, elaborate and analyse production data to identify waste and areas for improvement. Management of deviations, complaints and relative investigations with the identification and implementation of corrective and preventative actions. Maintain the department in a good state and ensure all housekeeping and maintenance activities are performed. Preparation and revision of all production batch documents and SOPs ensuring compliance with regulatory requirements. Management of the department budget and investment plans to ensure competitivity and cGMP compliance - anticipate technological developments to be one step ahead of regulatory requirements. Management of the full revamping project of the building in a fast-track mode to limit supply issue.

Manufacturing supervisor of a vaccine bulk unit (2 bulk aseptic areas). Managing day-to-day vaccines operations (cell cultures to virus harvest), manage a team of technicians (10 people). Responsible to implement continuous improvements in the facility to increase bulk potency for Polio and Measles Mumps Rubella /Varicella Vaccines. Ensure that the unit is in full compliance with GMP requirements. Process monitoring, yield trend analysis, audits, deviation management and continuous improvement activities

Manage a manufacturing unit of plastic piping extrusion processes (25 blue collars) in a day-to-day stressfull environment on a complete just-in-time integrated basis process. Project manager for installation of a modular software package for running all aspects of a manufacturing of plastic tubes and flexibles (MRPII software).

Chemical engineer and Master in administration and finance.