SYLVAIN DELEU
Conyers,GA
Summary
Accomplished Biopharmaceutical Manufacturing Professional with over 25 years of expertise in technical operations and supervision. Demonstrated success in supporting manufacturing of plasma-derived products, advancing from technician to supervisory and specialist roles. Proven experience in diverse environments within the biopharmaceutical sector.
Overview
1
1
Language
1
1
Certification
26
26
years of professional experience
Work History
Technical Specialist
Takeda Pharmaceuticals Company Limited
Social Circle, GA, USA
09.2024 - Current
- Technical specialist role supporting Takeda manufacturing operations for Gammagard Liquid product including operations such as cuno filtration, bulk filtration, nanofiltration, ANX and CMS chromatography, concentration, ultrafiltration, diafiltration and Biomax cassettes installation.
- Optimized production workflows to enhance operational performance.
- Developed troubleshooting protocols to resolve equipment issues, reducing downtime significantly.
- Oversee and streamline production operations.
- Ensure adherence to quality control standards and safety regulations.
- Led technical training sessions for staff to enhance product knowledge and operational efficiency.
- Owner of all technical documentation for compliance with industry standards and regulatory requirements.
- Collaborated with cross-functional teams to implement process improvements, resulting in enhanced workflow effectiveness.
- Worked with various departments to troubleshoot and resolve manufacturing challenges.
Operations Specialist II
Takeda Pharmaceuticals Company Limited
Social Circle, GA, USA
10.2020 - 08.2024
- Streamlined operational workflows to enhance efficiency and reduce cycle times.
- Coordinated cross-functional teams to ensure alignment on project objectives and deliverables.
- Analyzed data trends to identify process improvements and drive operational excellence.
- Implemented quality control measures, ensuring compliance with regulatory standards and best practices.
- Collaborated across departments to identify opportunities for process improvements and increased efficiency.
- Developed and maintained operational procedures, ensuring compliance with industry standards and facilitating regulatory adherence.
- Devised and implemented processes and procedures to streamline operations.
- Conducted regular reviews of operations and identified areas for improvement.
- Educated staff on essential manufacturing tasks to ensure operational efficiency.
Bulk Manufacturing Coordinator L4
Takeda Pharmaceuticals Company Limited
Lessines, Belgium
10.2021 - 09.2022
- Temporary back on Lessines site due to administrative issue
- Coordinated bulk manufacturing operations in Lessines to ensure production alignment with organizational goals.
- Coordinated cross-functional teams to streamline manufacturing processes and enhance operational efficiency.
- Authored investigation reports related to manufacturing deviations.
Operations Specialist I
Shire Pharmaceuticals
Social Circle, GA, USA
02.2017 - 09.2020
- Identified and implemented improvement initiatives to improve yield, reliability, and/or process robustness.
- Collaborated to address environmental, health, and safety (EHS) needs and mitigate associated risks.
- Identified and implemented improvement initiatives to improve yield, reliability, and/or process robustness.
- Enhanced technical understanding and problem-solving skills in biopharmaceutical processes.
- Organized data and prepared appropriate documentation, including presentation materials, for assigned projects.
- Facilitated CAPA investigations to ensure compliance with regulatory standards and improve processes..
- Facilitated problem-solving sessions to address operational challenges and develop solutions. Root-cause analysis sessions.
- Interacted with Quality, Engineering and Tech Service departments.
- Acted as the main point of contact for Change Controls (CC) in the purification department.
- Multiple CCs Owner in Track-wise system and ensured appropriate CC assessments are timely completed.
- Trained manufacturing staff on changes to procedures and processes.
Bulk Manufacturing Supervisor L1, 2, 3 & 4
Baxter Bioscience / Baxalta / Shire Pharmaceuticals
Lessines, Belgium
03.2009 - 02.2017
- Supervised bulk manufacturing activities for L1, L2, L3, and L4 operations, ensuring alignment with production objectives.
- Oversaw daily operations of manufacturing processes, ensuring compliance with safety and quality standards.
- Managed a team of 10+ technicians to ensure scheduling and production targets while minimizing downtime.
- Oversaw daily manufacturing operations, ensuring adherence to safety regulations and quality standards.
- Collaborated with cross-functional teams to streamline communication and enhance productivity across departments.
- Supported technology transfer as Technician at Shire in Social Circle, GA, USA, facilitating successful implementation of production processes from August to December 2016. (focus engineering runs and conformance lots)
- Collaborated with cross-functional teams to streamline processes and enhance workflow efficiency.
- Maintained records of team attendance and hours to support personnel management.
- Analyzed accident reports to determine contributing factors and improve safety protocols.
Bulk Manufacturing Lead L1
Baxter Bioscience
Lessines, Belgium
03.2004 - 03.2009
- Executed bulk manufacturing tasks in L1 operations including filtration, ultrafiltration, and chromatography to ensure product quality.
- Contributed to successful production of Gammagard SD product, supporting overall production goals.
- Acted as manufacturing back-up supervisor for L1 bulk manufacturing activities.
Bulk Manufacturing Technician L1
Baxter Bioscience
Lessines, Belgium
03.2001 - 03.2004
- Executed bulk manufacturing technician tasks in L1 operations, including filtration, ultrafiltration, and chromatography, ensuring compliance with production standards.
- Contributed to Gammagard SD product production to ensure quality and efficiency.
Interim Production Technician
Pollet Company
01.2001 - 02.2001
Temporary / Interim Work Assignments
09.2000 - 12.2000
- Rénov'action, Rosier fertilizers, Yplon
Interim Stock Management
06.2000 - 09.2000
- 3 Suisses
Education
High School Diploma - Option Laboratory Technician
HEPHO
Irchonwelz06-2000
Certificat d'Etudes de base (CEB) - Mathematics, Biology, Chemistry & Languages
Ecole des Frères de Tournai
Tournai06-1997
Skills
- Anion Exchange (ANX) and Carboxymethyl Sepharose (CMS) packing operations
- Nanofiltration and nanofilter testing
- Ultrafiltration / diafiltration
- Manufacturing Supervision & Team Leadership
- Data Analysis Tools
- Software such Electronic Batch Management (EBM), JDEdwards (JDE), Delta V, Success Factor, Veeva and Trackwise
Certification
Yellow Belt Certification
LANGUAGES
Languages: French (native), English (professional).
Interests
Travelling and discovering new places, Soccer fan and occasional player with friends after work and during weekends, Workout at the gym daily
TRAINING & CERTIFICATIONS
Management Training – 2005 (3 days; required as a Manufacturing Lead)
Timeline
Technical Specialist
Takeda Pharmaceuticals Company Limited
09.2024 - Current
Bulk Manufacturing Coordinator L4
Takeda Pharmaceuticals Company Limited
10.2021 - 09.2022
Operations Specialist II
Takeda Pharmaceuticals Company Limited
10.2020 - 08.2024
Operations Specialist I
Shire Pharmaceuticals
02.2017 - 09.2020
Bulk Manufacturing Supervisor L1, 2, 3 & 4
Baxter Bioscience / Baxalta / Shire Pharmaceuticals
03.2009 - 02.2017
Bulk Manufacturing Lead L1
Baxter Bioscience
03.2004 - 03.2009
Bulk Manufacturing Technician L1
Baxter Bioscience
03.2001 - 03.2004
Interim Production Technician
Pollet Company
01.2001 - 02.2001
Temporary / Interim Work Assignments
09.2000 - 12.2000
Interim Stock Management
06.2000 - 09.2000
Certificat d'Etudes de base (CEB) - Mathematics, Biology, Chemistry & Languages
Ecole des Frères de Tournai
High School Diploma - Option Laboratory Technician
HEPHO