Process Development Engineer

• Feb 2023 - Present

Project manager for process scale up: -Define project strategy -Realize process development and validation -Manage resources and timelines -Write and verify the quality documentation of the project

Process Development Engineer (agap2 consultant)

• Apr 2022 - Jan 2023

-Determine development strategy -Manage timeline and achievements-Create and perform Design of experiment for laboratory test and manufacturing test-Develop a new process on a new production line (feasibility runs, data analysis, writing of quality documents) -Validation of a new process

Life Sciences Consultant

• Jul 2020 - Feb 2023

07/2020-10/2020 and 04/2022-02/2023: Process development engineer: -Development and validations of a new processes -Execution of the investigation following a DMAIC approach -Creation and execution of design of experiment for laboratory test July 2021-Now : Process engineer for vaccine drug substance production: Deviation manager for Moderna Covid-19 Vaccine: -Investigation on deviations -Assessment of product impact quality -Definition and application of corrective and preventive actions October 2020-June2021: Manufacturing and qualification engineer : As a member of Manufacturing and MSAT teams, my tasks were to support the installation of the Biotech plant with the qualification and the commissioning of the new USP, DSP and utilities equipments for both laboratories and large-scale manufacturing Qualification and commissioning of equipments -Define the qualification strategy based on URS and Process specifications -Writing qualification and commissioning protocols: FAT, SAT, IQ, OQ, PQ -Execution of the qualification and commissioning -Review of executed protocols and reports -Management of supplier qualification MSAT support -Writing and approval of Standard Operating Procedure -Writing Protocol for process development (cell culture: definition of kLa and mixing time) Show less

Process engineer for Moderna Covid-19 Vaccine (agap2 consultant)

• Jul 2021 - Mar 2022

Deviation manager for Moderna Covid-19 Vaccine: -Investigation on deviations -Assessment of product impact quality -Definition and application of corrective and preventive actions Deviation manager for Moderna Covid-19 Vaccine: -Investigation on deviations -Assessment of product impact quality -Definition and application of corrective and preventive actions

Manufacturing and qualification engineer (agap2 consultant)

• Oct 2020 - Jun 2021

As a member of Manufacturing and MSAT teams, my tasks were to support the installation of the Biotech plant on Yverdon site with the qualification and the commissioning of the new USP, DSP and utilities equipments for both laboratories and large-scale manufacturing Qualification and commissioning of equipments -Define the qualification strategy based on URS and Process specifications -Writing qualification and commissioning protocols: FAT, SAT, IQ, OQ, PQ -Execution of the qualification and commissioning -Review of executed protocols and reports -Management of supplier qualification MSAT support -Writing and approval of Standard Operating Procedure -Writing Protocol for process development (cell culture: definition of kLa and mixing time) Show less

Life Sciences Consultant

• Mar 2020 - Jun 2020

Eco-volunteer for marine conservation (Belize)

• Jan 2020 - Feb 2020

Belize barrier reef reserve system is the second largest barrier reef of the world. As the other barrier reefs of the world, the Belizean one is endangered because of global warming and others human activities like overfishing, pollution... -Fish and mussel surveys to calculate fishing quota. (snorkeling diving) -Coral surveys to ensure of the health of the barrier reef reserve. (Scuba diving) -Analyze of samples to ensure that the commercial production of seaweed has no impact on the marine environment. -Hunting of invasive species to avoid destruction of the fauna. (Scuba Diving skills) Show less

Project Manager Officer at Technical Department

• Jan 2019 - Dec 2019

-Management and coaching of 2 consultants on product development projects (Baxter)-Creation and Harmonization of KPI to follow the projects of three departments-Analysis and improvement of a process of subsidies recovery (DMAIC methodology) -Development of a tools to follow the activity of a team of consultants and forecast the activities-Writing of technical sections of bids-Calculation of standard time for different activities in order to control the productivity-Creation and participation in steering committees Show less

Life Sciences Consultant (Baxter, Process Development)

• Nov 2016 - Dec 2018

First assignement: Baxter: Research associate in Process Development Project 1: Ansidine project Project 2: pFAT 5 Project 3: Oxygen investigation Project 4: Tech transferBaxter Site Leader for Alten consultants: -Technical referent for the client -Creation of team spirit between Alten consultants

Process Development Engineer

• Nov 2016 - Dec 2018

Research associate in Process Development for the department "Pharmaceutical Development" Project 1: Ansidine project: To optimize the process in order to reduce oxidation reaction following a Chinese Pharmacopeia modification. Project 2: pFAT 5: To find and solve the root cause of the presence of too large amout of big globules in the emulsion of a new product. Project 3: Oxygen investigation: To Reduce dissolved oxygen concentration into the finish product Project 4: Tech transfer -Investigation management: QBD method (DOE, DMAIC) -Statistical analysis (Minitab)) -Extraction of process data from manufacturing software (Elan, Active Factory and report viewer). -Write Protocols, Reports and Trial Requests -Realize lab, pilot and manufacturing tests (Role of engineer, manager, and scientist) -Work into production (supervision of R&D manufacturing production) -Optimize process (modification of parameters or production unit) -Meeting with management and executive members (English and French) -Perform analytical tests and development of new methods -Scale down of pilot lab to laboratory scale Show less

Product steward

• Mar 2016 - Aug 2016

RESPONSIBILITIES: To verify the quality of the product and of the process for different pipelines -Solve production issues. -Optimize chromatography step. Increase the yield according to GMP rules. Gain of 8% of yield for a very expensive drug substance. -Put in place of expectation limits (limit stricter than specification limit to avoid production stop) thanks to statistics method (Minitab, 6sigma…) -Creation of a retreatment protocol in order to separate drug substance and excipient because of a microbiologic pollution during last steps of production. Results: Retreatment of 300Kg of drug products. Laboratory work to find the best parameters. -Writing quality reports. -English speaking environment. Show less

Industrial research project

• May 2015 - Jul 2015

Management of a project under an industrial agreement. Organic and inorganic analysis (TLC, NMR ( 13 C, 1 H), HPLC, Spectroscopy, GC, biologic test) of a natural product in view of commercialization. And realize a part of an European program. Study of floor influence on growth of a vine disease mushroom (Spectroscopy, microbiology). Management of a project under an industrial agreement. Organic and inorganic analysis (TLC, NMR ( 13 C, 1 H), HPLC, Spectroscopy, GC, biologic test) of a natural product in view of commercialization. And realize a part of an European program. Study of floor influence on growth of a vine disease mushroom (Spectroscopy, microbiology).

Operator

• Jul 2014 - Aug 2014

Impregnation of pellet with active principle. Learning of GMP rules. Impregnation of pellet with active principle. Learning of GMP rules.

Operator

• Jul 2012 - Jul 2012