Program Leader

• Aug 2022 - Present

- Project Management Organization implementation at corporate scale - Transversal program management of two early biotechnological products (therapeutic anti-HPV vaccine & prophylactic COVID-19 vaccine based on the same anti-CD40 fused protein platform) from preclinical phase up to clinical Phase I/IIa - Project meeting organization with cross-functional and multidisciplinary teams (preclinical, CMC, regulatory, clinical, quality), writing of agenda & minutes - Tools implementation:… Show more - Project Management Organization implementation at corporate scale - Transversal program management of two early biotechnological products (therapeutic anti-HPV vaccine & prophylactic COVID-19 vaccine based on the same anti-CD40 fused protein platform) from preclinical phase up to clinical Phase I/IIa - Project meeting organization with cross-functional and multidisciplinary teams (preclinical, CMC, regulatory, clinical, quality), writing of agenda & minutes - Tools implementation: planning (Microsoft Project software), roadmap, dashboards, reporting on milestones - Scientific & competitive watch management Show less - Project Management Organization implementation at corporate scale - Transversal program management of two early biotechnological products (therapeutic anti-HPV vaccine & prophylactic COVID-19 vaccine based on the same anti-CD40 fused protein platform) from preclinical phase up to clinical Phase I/IIa - Project meeting organization with cross-functional and multidisciplinary teams (preclinical, CMC, regulatory, clinical, quality), writing of agenda & minutes - Tools implementation:… Show more - Project Management Organization implementation at corporate scale - Transversal program management of two early biotechnological products (therapeutic anti-HPV vaccine & prophylactic COVID-19 vaccine based on the same anti-CD40 fused protein platform) from preclinical phase up to clinical Phase I/IIa - Project meeting organization with cross-functional and multidisciplinary teams (preclinical, CMC, regulatory, clinical, quality), writing of agenda & minutes - Tools implementation: planning (Microsoft Project software), roadmap, dashboards, reporting on milestones - Scientific & competitive watch management Show less

Pharmaceutical Operations Manager

• May 2020 - Aug 2022

- Project Management of a late-stage Medical Device/Drug (with a CMC focus on formulation process development, industrial transposition, process validation, GMP manufacturing for Phase III clinical trial and associated stability studies) - Management of various EU subcontractors including CMOs, suppliers and external labs (contracts implementation, budgets negotiation and regular follow-up) - Strategic planning implementation and monitoring (at CMC department and at corporate scales)… Show more - Project Management of a late-stage Medical Device/Drug (with a CMC focus on formulation process development, industrial transposition, process validation, GMP manufacturing for Phase III clinical trial and associated stability studies) - Management of various EU subcontractors including CMOs, suppliers and external labs (contracts implementation, budgets negotiation and regular follow-up) - Strategic planning implementation and monitoring (at CMC department and at corporate scales), reporting on critical milestones (Microsoft Project software) Show less - Project Management of a late-stage Medical Device/Drug (with a CMC focus on formulation process development, industrial transposition, process validation, GMP manufacturing for Phase III clinical trial and associated stability studies) - Management of various EU subcontractors including CMOs, suppliers and external labs (contracts implementation, budgets negotiation and regular follow-up) - Strategic planning implementation and monitoring (at CMC department and at corporate scales)… Show more - Project Management of a late-stage Medical Device/Drug (with a CMC focus on formulation process development, industrial transposition, process validation, GMP manufacturing for Phase III clinical trial and associated stability studies) - Management of various EU subcontractors including CMOs, suppliers and external labs (contracts implementation, budgets negotiation and regular follow-up) - Strategic planning implementation and monitoring (at CMC department and at corporate scales), reporting on critical milestones (Microsoft Project software) Show less

Corporate Development Manager

• Apr 2019 - May 2020

- Project Management of a UCART-cell product: global planning implementation (Microsoft Project software) and follow-up with transversal teams, with a specific focus on CMC activities - Quality by Design strategy implementation: Quality Target Product Profile (QTPP), risk analysis performance (PHA/FMEA/HACCP) to identify product CQAs and process CPPs - Project Management of a UCART-cell product: global planning implementation (Microsoft Project software) and follow-up with transversal teams, with a specific focus on CMC activities - Quality by Design strategy implementation: Quality Target Product Profile (QTPP), risk analysis performance (PHA/FMEA/HACCP) to identify product CQAs and process CPPs

Process Development Engineer

• Feb 2017 - Apr 2019

- Scale up of a red blood cells manufacturing process from HSCs - Process optimization through Design of Experiments and new technologies implementation - ESH strategy design and launch (chemical risk management) - Equipment maintenance management (contracts, planning, budgets) - Scale up of a red blood cells manufacturing process from HSCs - Process optimization through Design of Experiments and new technologies implementation - ESH strategy design and launch (chemical risk management) - Equipment maintenance management (contracts, planning, budgets)

Upstream Process Engineer

• Aug 2015 - Feb 2017

- GMP Upstream Process monitoring (monoclonal antibody production at 10,000 L scale) - Change control / CAPA implementation - Deviation investigation - Process validation

Intern R&D Bioprocess

• Apr 2015 - Aug 2015

- Development of an upstream bioprocess in sterile 5L bioreactor (monoclonal antibody production by CHO cells) - Design of Experiment approach implementation - Literature investigation

Stagiaire en optimisation de procédés

• Jun 2014 - Sep 2014

API manufacturing process optimization KPI implementation Deviation investigation API manufacturing process optimization KPI implementation Deviation investigation

Magasinier

• Feb 2013 - Mar 2013