Flavio Lippi
Colle Di Val D'Elsa (SI),13
Summary
Accomplished MSAT Process Science Manager with a proven track record at GSK , enhancing production efficiency and product quality through expert application of new technologies and innovative idea. Skilled in leading teams to innovate and implement process improvements, demonstrating exceptional innovation attitude and networking capacity.
High knowledge of primary vaccines process and product with capacity of problem solving.
Technical and scientific Leadership recognized by the team and stakeholders.
Open and honest conversation with the team and stakeholders.
Team working skill to motivate all the team where is involved.
Overview
29
29
years of professional experience
Work History
MSAT Process Science Upstream Lab Manager
GSK
03.2023 - Current
- Manage of Manufacturing science and technologies Process Science Upstream Lab for pilot and small scale production processing in support of one or more production area
- Lead the Process science Performance improvement primary team to propose the process improvement and support Manufacturing trouble shooting
- Support the MSAT Process science Head to define budget and investment
- Support and coordinate, in collaboration with the other lab manager, the new global platform (is. sterile filtration platform)
- Lead motivate and develop the lab based staff and manage the people's
- Coordinate the lab activity and project
- Design the experiments and improve the commercial process according the QbD approach
- Support and coordinate the Manufacturing tech transfer of process improvements
- Manufacturing support for trouble shooting
- Networking activity to increase the knowledge of new technologies
- Ensure the health and safety roles and culture
- Scientific knowledge diffusion in the company network and site
MSAT Process Science Downstream Lab Manager
GSK
01.2015 - 03.2023
- Manage of Manufacturing science and technologies Process Science Downstream Lab for pilot and small scale production processing in support of one or more production area
- Support the MSAT Process science Head to define budget and investment
- Lead motivate and develop the lab based staff and manage the people's
- Coordinate the lab activity and project
- Design the experiments and improve the commercial process according the QbD approach
- Support and coordinate the Manufacturing tech transfer of process improvements
- Manufacturing support for trouble shooting
- Networking activity to increase the knowledge of new technologies
- Ensure the health and safety roles and culture
- Scientific knowledge diffusion in the company network and site promoting the Downstream SME Global community
MSAT Primary Process Expert
Novartis
01.2013 - 01.2015
- Manufacturing support in term of process trouble shooting
- Product quality impact assessment definition in the deviation report
- CAPA identification and implementation
- Change request evaluation in term of product quality impact and technologies application
- QRA (quality risk assessment) and TRA (technical risk assessment) definition, applying the QbD approach
- Tech transfer and Process validation support
- HA inspection (FDA, EMA) support as SME
Manufacturing Primary Process Specialist
Novartis
01.2008 - 01.2013
- Support the Manufacturing operator and team coordinator in the production activity
- Support the Manufacturing manager in the budget definition
- Ensure the GMP application on the shop floor
- SOP, BPR definition and revision
- Deviation report management and root cause analysis
- CAPA definition and implementation
- Change request evaluation and implementation
- Technical training to the operator
Manufacturing Operator and Supervisor
Chiron
10.1995 - 01.2008
- Primary operator in fermentation and purification manufacturing
- Primary supervisor in fermentation and purification, coordinating the team of about 5 people's
- Ensure the GMP and the correct documentation application
- SOP definition and document revision
TRD Expert Job Rotation
Chiron
01.2000 - 01.2001
- Participate to the Helicobacter pylori vaccines team project in the clinical phase 2, working in the development of downstream process
Education
Bachelor of Science - Biotechnology
Università Degli Studi Di Siena
Siena Italy10.1998
Skills
- Primary processes technologies (Fermenter, Centrifuge, Ultrafiltration, filtration and Chromatography)
- SUS systems (Vessel, Fermenter)
- QbD approach
- DMAIC approach
- GMP roles
- Vaccines Glyco conjugate processes
- PAT technologies and chemiometric model knowledge
- Team working
- Leadership
- Pragmatic and realistic attitude
- Innovation attitude
- Networking capacity
Languages
Italian
Bilingual or Proficient (C2)
English
Upper intermediate (B2)
Hobbies
- Politician, Former Councilor at Municipality
- Sport Fishing
Timeline
MSAT Process Science Upstream Lab Manager
GSK
03.2023 - Current
MSAT Process Science Downstream Lab Manager
GSK
01.2015 - 03.2023
MSAT Primary Process Expert
Novartis
01.2013 - 01.2015
Manufacturing Primary Process Specialist
Novartis
01.2008 - 01.2013
TRD Expert Job Rotation
Chiron
01.2000 - 01.2001
Manufacturing Operator and Supervisor
Chiron
10.1995 - 01.2008
Bachelor of Science - Biotechnology
Università Degli Studi Di Siena
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