Guillaume M.

PharmD | Aseptic Manufacturing & Logistics | QA | Manager | SAP EWM Key User

Switzerland

About

I've spent over a decade making sure life-saving therapies reach patients, safely, on time, and in full compliance. My career sits at the intersection of two demanding disciplines: aseptic manufacturing (Fill & Finish) and pharmaceutical logistics. At Incyte Bioplant in Switzerland, I currently oversee warehouse and logistics operations including SAP EWM, while serving as Subject Matter Expert for Fill & Finish, a dual role that keeps me equally close to production floors and supply chain strategy. Over the years, I've led pharmaceutical site of 45+ people, managed multi-million-euro budgets, and been involved in projects that matter: launching a new multiproduct aseptic filling line for albumin and IgG, onboarding new clients and products, and acting as SME during regulatory inspections with Swissmedic, FDA, ANVISA, and ANSM. What I bring beyond the technical expertise is a hands-on leadership style. I build teams that own their work, solve problems before they escalate, and perform under the pressure that biopharmaceuticals demand. Beyond operations, I am developing hands-on coding skills, from VBA automation to Business Intelligence (BI), which I apply to streamline reporting, improve data visibility, and build tools that make teams more efficient. If you're working at the crossroads of biopharma operations, GMP/GDP compliance, or supply chain in the life sciences space, I'd be glad to connect

Experience

  • Incyte ()
    • Manager - Warehouse & Logistics
      Oct 2023 - Present · 2 yrs 10 mos

      - Management of the Bioplant logistics team and 2 overflow sites - SAP-EWM Key User: support for WH/MFG teams, incident tracking - Department representative during audits (Swissmedic, FDA, ANVISA, internal, Finance) - Quality System - Veeva: owner of quality records for the logistic department (deviation, CAPA, Change Control)

    • Consultant - Warehouse Manager
      Apr 2023 - Sep 2023 · 6 mos

  • Voyage at Career Break
    Aug 2021 - Mar 2023 · 1 yr 8 mos

    World Tour : Latin America, USA, Australia and East Asia

  • Operations Manager – Pharmacist / Qualified Person Deputy at STEF
    Oct 2018 - Jul 2021 · 2 yrs 10 mos

    - Logistics Operations Manager for medicines and medical devices - Team management (45 people): 1 deputy, 4 department heads, 1 HR assistant - Member of the company’s decision-making committees - Budget management (annual turnover: ~€6 million) and customer billing - Customer relationship management with suppliers and partners - Audits & Inspections: ISO 9001, ISO 13485, customers, and health authorities - Project leader and sponsor for new customer/product onboarding: IT, logistics, audits/inspections

  • Production Pharmacist - Fill & Finish and Freeze Drying at Octapharma Lingolsheim
    Jul 2015 - Oct 2018 · 3 yrs 4 mos

    Pharmaceutical Manufacturing Department – Lyophilization and Aseptic Processes - On-call process support: management of production incidents - Operational, quality, and documentation support for departmental teams - Compliance oversight of aseptic processes: lyophilization, sterilization, washing/depyrogenation, sterile filtration, viral inactivation, etc. - Handling of deviations, CAPA, and change control actions (TrackWise) - Participation in Media Fill Tests (Aseptic Process Simulations) - Monitoring of cleanroom reset activities (Grade A/B) after maintenance shutdowns Key project: project team member for the implementation of a new multiproduct aseptic filling line (albumin and IgG): - Support for operational development on the line (setup, interventions, environmental monitoring) - Frequent travel to the equipment supplier in Germany - Drafting of SOPs and working instructions - Full redesign of batch records with the creation of a campaign-mode structure Deputy Pharmacist: oversight of pharmaceutical operations in compliance with the French Public Health Code

  • LFB Biomédicaments (1 yr 10 mos)
    • Production Team Leader - Night shift Pharmacist
      Jul 2014 - Jun 2015 · 1 yr

      𝙇𝙖𝙗𝙤𝙧𝙖𝙩𝙤𝙞𝙧𝙚 𝙛𝙧𝙖𝙣𝙘̧𝙖𝙞𝙨 𝙙𝙪 𝙁𝙧𝙖𝙘𝙩𝙞𝙤𝙣𝙣𝙚𝙢𝙚𝙣𝙩 𝙚𝙩 𝙙𝙚𝙨 𝘽𝙞𝙤𝙩𝙚𝙘𝙝𝙣𝙤𝙡𝙤𝙜𝙞𝙚𝙨 (𝙇𝙁𝘽) - 𝙇𝙁𝘽 𝘽𝙞𝙤𝙢𝙚́𝙙𝙞𝙘𝙖𝙢𝙚𝙣𝙩𝙨 - Management of 15 technicians across 3 purification workshops - Handling production contingencies and deviation/CAPA management - Implementation of a performance indicator (OEE)

    • Assistant de Production
      Sep 2013 - Aug 2014 · 1 yr

      ▪ Amélioration continue (qualité / sécurité / rendement / productivité) ▪ Ateliers Immunoglobulines liquides, Immunoglobulines lyophilisées, Facteur XI, Alpha 1 antitrypsine/Albumine, Fibrinogène ▪ Élaboration et mise en place d'un TRS (Taux de Rendement Synthétique) sur un équipement non cadencé ▪ Équipier projet LEAN Manufacturing : optimisation des temps productifs des équipements ▪ Supervision et préparation de changements industriels dans le respect des BPF ▪ Participation à la gestion des déviations et CAPA (QMS TrackWise) ▪ Utilisation de l'outil ERP Qualiac