Lucerne, Lucerne, Switzerland
- Project Manager for implementing new technologies in clinical manufacturing, leading projects from concept through GMP release, ensuring cross-functional integration. - Project Manager for harmonizing single-use components across manufacturing sites, standardizing processes, and improving efficiency. - Capital Projects Coordinator responsible for managing budgets and overseeing capital projects, ensuring alignment with organizational priorities. - Subject Matter Expert in evaluating and optimizing innovative equipment, preparing user requirements, and managing capital funding proposals for process improvements.
Led cross-site harmonization and implementation of 100+ single-use assemblies and enabling technologies, enabling material sharing across sites while supporting compliant implementation, GMP readiness, and supply continuity. Developed template BOMs and fallback solutions for critical materials to de-risk implementation, simplify tech transfers, and strengthen manufacturing continuity and supply chain robustness. Advanced technology and equipment initiatives including ATF10 LS controller, DynaDrive bag inflation, and MFC TruFlow replacement to strengthen automation readiness, process capability, and future manufacturing capacity. Led the Calibration Harmonization Project, ensuring calibration and process specifications were aligned with pharmaceutical inspector expectations, including Swissmedic, and successfully defending the approach during an internal audit. Managed selected CAPEX and non-CAPEX initiatives from business case through implementation, supporting site priorities in manufacturing capability, compliance, and continuity.
- Lead both shop floor operations and line management, overseeing daily production activities and managing a high-performance team. - Act as a Subject Matter Expert (SME) during GMP audits and regulatory inspections, ensuring compliance with global standards. - Pioneered the adoption of Automated Visual Inspection technology to enhance product quality and operational efficiency. - Manage personnel development within the production team, fostering collaboration and driving operational excellence. - Lead GAP assessments to ensure compliance with Annex 1 standards, implementing continuous improvement initiatives.
▪ Working as DPD expert for biosimilars in project teams with different functions: regulatory, analytics, QA and production; ▪ Been supportive as DPD expert for EU and US approval of biosimilar Hyrimoz® (Adalimumab) for subcutaneous injection; ▪ Planning, supervising and evaluating studies on process development and characterization for sterile liquid drug product (DP) in syringes (LISY) from DS thawing up to visual inspection of final DP; ▪ Supporting tech transfer of the DP formulation and process knowledge from pilot scale to commercial scale under GMP; ▪ Attending and supporting the operational execution of DP pre- and process validation batches at commercial scale; ▪ Writing documentation for aseptic DP manufacturing process at commercial scale for pre- and process validation batches; ▪ Reviewing Batch Records of DP manufacturing at commercial scale for pre- and process validation batches; ▪ Responsible for the scale-down model of the DP manufacturing process; ▪ Supporting regulatory filing and question answering of biosimilar dossiers to pharmaceutical drug authorities (EU and US); ▪ Part of the networking for DP process optimization of unit operations for DP compounding up to filling; ▪ Participating as team member in root cause investigations and in decision on CAPA implementation; ▪ Supporting evaluation action and modification action as part of change control; ▪ Supporting DP projects for risk evaulation and risk mitigation by simulation and optimization of unit operations from compounding up to filling with mathematical models; ▪ Evaluating graphically and statistically the DP analytical results at release and under stability (over shel-life); ▪ Evaluating DP process capability and process performance at commercial scale by graphical and statistical analyses; ▪ Leading collaboration with process material supplier and testing laboratories; ▪ Implementation ICH guidelines and Quality by Design (QbD) concepts DP development activities.
Contributed to Drug Product process development for sterile liquid biosimilars in syringes for EU and US submissions. Led studies for DP process development, scale-down, and characterization at lab scale. Supported scale-up, tech transfer, and GMP validation across 2 CMOs and 1 internal site. Collaborated with cross-functional teams including analytics, production, regulatory, and QA to prepare regulatory documentation, risk assessments, scientific reports, and support unit operation modelling. Implemented validation strategies including bracketing, matrix, and worst-case approaches to streamline processes.
Authored and implemented validation and bracketing strategies for microbial retention studies, process simulation revalidation, CCIT, and visual inspection, reducing validation effort while strengthening compliance and manufacturing efficiency. Drove technical improvements to fill-finish setup, assemblies, and filtration steps, including low-volume filling changes, a recirculation system to reduce product loss during filter wetting and integrity testing, and pressure-equilibration improvements to strengthen process robustness and compliance. Led the Automated Visual Inspection program from machine selection through design strategy, benchmarking solutions, coordinating vendors and cross-functional stakeholders, and presenting business risks and technical recommendations to senior management for approval. Completed a 3-month US rotation across Rahway and West Point, supporting CQV / FLEX readiness for OSD operations and leading a project to reduce turnaround time for potent compound manufacturing.