Thun, Berne, Switzerland
I am a motivated GMP allrounder with experience in the pharmaceutical industry, special focus vaccine manufacturing and continuous improvement. I am experienced in document generation and improvement (i.e. batch records, SOPs,etc.), investigations and change management (Trackwise, Veeva and Reliance) as well as batch and production planning, TPM and scheduling. Additionally, I had the opportunity to gain experience switching paper based documentation to automated eBRs and to improve and design eBRs (MES Syncade) ,implement new products and improve existing eBRs and processes. Furthermore, I supported multiple tech transfers with line start-ups and ramp-ups in different companies, hence I have insights into project scheduling, qualification and comissioning, etc. I have been directly involved in multiple audits (routine and pre licensing inspections, FDA and Swissmedic). Also, I currently have the honour to lead a great team (aprox.25 people) and to support the development of individuals working in upstream, and downstream. My direct reports include individual operators, specialists and team leads with managing responsibilities. I started my work in the pharmaceutical industry on a shopfloor level (BSL3 and clean room class C/B) and hence I believe in empowering the shopfloor and a data-driven common language as critical organizational success factors. My peers know me as motivated, enthusiastic and energetic colleague. My leadership credo is "if you are called to lead -you are called to serve" and I believe that a good team is a company's most valuable asset. Hence, i like to hire the right people, empower and enable them and then get out of their way to let them perform. I am holding a BSc in "Medical and Pharmaceutical Biotechnology" and additionally completed the MSc program "Engineering Management" at Brunel University London in summer 2022. During my studies I worked in research labs in Vienna, Lisbon and Boston and loved the international and inspirational exposure. To continue my education I am currently aiming for a CAPM certification with the goal to develop myself into a PMI certified PMP in the future.
Responsible for oversight of department; direct reports include the upstream,downstream and formulation team leads, manufacturing specialists and clean room operators. (transition of site from Emergent Biosolutions to Bavarian Nordic). Q2/Q3 2025: internal switch to new vaccine project, ramp up of new facility and build-up of team, tech transfer support. New direct reports include upstream and downstream team leads, specialists, clean room operators and material planners
Responsible for oversight of department; direct reports include the upstream,downstream and formulation team leads and clean room personell.
Bioprocessengineer in a large-scale Covid-19 mRNA vaccine manufacturing project duties include: - daily manufacturing support - batch scheduling, batch planning and CT improvement - Deviation and Change Management (Trackwise) - MBR, eBR (Syncade) and process improvement - MBR and eBR creation, improvement and review (MES Syncade) - leading project work, tech transfers and new product comissioning
Placement at Lonza Visp site, manufacturing specialist and Bioprocess Engineer for mRNA vaccine production, Covid-19 project main duties include: - document generation and improvement (MBRs, SOPs, etc.) - support of deviations, change management and CAPAs (Trackwise) - batch record review and improvement
Specialist ( IPT soft chew Packaging) duties of this role include: - CAPA &change control (Trackwise) - process improvement and optimization - project work - problem reporting, investigation and deviation processing, solution development & implementation -batch lifecycle processing (SAP)