Switzerland
As a Quality Assurance Project Manager in Lonza’s Bioconjugates business, I serve as the key QA interface between customers, manufacturing, and cross-functional teams — ensuring every product meets the highest GMP and compliance standards from development through commercial production. I also lead the Microbial Contamination Control (MCC) strategy for Bioconjugates at Lonza Visp, representing the site in the global MCC network and driving the vision of “Version Zero Contaminations.” My focus is on building robust processes, aligning site practices with global standards, and fostering a proactive culture of prevention and ownership. Highlights: - Act as the QA lead and single point of contact for multiple antibody-drug conjugate (ADC) projects, both clinical and commercial. - Drive the implementation of new customer quality frameworks, including Quality Agreements, process concept changes, filing and readiness activities. - Lead cross-functional MCC core teams (QA, MSAT, Manufacturing) and conduct GEMBA walks to identify and implement contamination prevention improvements. - Represent Lonza Visp globally, ensuring Swiss operations integrate and execute global contamination control standards effectively. - Lead batch release activities, including the review and approval of critical GMP documentation — risk assessments, deviations, CAPAs, master batch records, SOPs, QC plans, and parameter lists. - Host the Deviation Review Board (DRB), ensuring accurate assessment, categorization, and timely closure of deviations. Coaching of other Employees in Deviation Management. - Champion Data Integrity, serving as an ambassador and promoting a culture of transparency and compliance. - Recognized for strong leadership, cross-functional collaboration, and problem-solving skills, consistently praised by management as a trusted partner and top performer. - Ongoing Lean Six Sigma Green Belt project reducing QA processing times and improving operational efficiency.
- Leading Inoculum and Wave process steps by planning, executing and documenting during project/production start-up phases - Process transfer implementation from UK to Switzerland new venture project IBEX - Creation and Implementation of GMP MES/DeltaV recipes using Syncade - Creation and Implementation of GMP documentation (Process SOPs, Risk Assessments, Trainings,...) - Establishment of Aseptic Training Requirements and Documentation - Single-use Technology
Continuous Fermentation of Chinese Hamster Ovary Cells (CHO) for maintenance energy determination - Non-producer cell line CHO-K1 supplemented with Glutamine or adapted to Glutamine-free Media - Upstream - AG Borth, BOKU in cooperation with SANDOZ and ACIB
Heterologous expression of VP28 in Lactobacillus plantarum with suitable anchoring motifs and feeding strategies as vaccination possibility for shrimp against WSSV - Part of this work (3 months) will be completed in Hanoi University of Science and Technology (HUST) in Hanoi, Vietnam - Tasks involved: molecular - and microbiological techniques (cloning, PCR, cultivation strategies, SDS-Page, Western Blot), Batch Fermentation, Feeding Experiments for Shrimp Aquaculture using L.vannamei, Flow Cytometry, Indirect Immunofluorescence Microscopy
Bioprocess Engineering (Fermentation group) of Dr. Striedner Analysis of proteins including preparation of required solutions (trace element solution, fixing solution, media preparation, staining and destaining solution) cell lysis/disruption, SDS-Page, Western Blot, sampling of ongoing fermentation, cleaning and sterilisation of fermentation reactor, microscopic exclusion of contamination, interpretation of results
GMP Support