Munich, Bavaria, Germany
Advanced professional training in: - ICH GCP (ICH Guideline E6(R3), EU Clinical Trials Regulation 536/2014, FDA Form 1572) - ASQ Certified Pharmaceutical GMP Professional (CPGP) - Biotechnology - Fermentation Technology - Career Transition Program – Practical Training in GMP Quality Assurance at Nuclidium AG
- CMC Quality Lead for the Pembrolizumab biosimilar program through process validation (PPQ). - Provided QA oversight for GMP-compliant manufacturing across drug substance (DS), bulk and finished drug product (DP/FDF), and investigational medicinal products (IMP). - Acted as primary QA contact for external Qualified Persons (QPs) and CMO quality teams, internal cross-functional teams, and external partners. - Reviewed and approved process validation (PPQ) and analytical method validation (acc. to ICH) in collaboration with subject matter experts (SMEs). - Negotiated and drafted quality assurance agreements (QAAs) and QP-to-QP agreements with external partners. - Reviewed and approved QA CMC-related and batch documentation. - Supported the IMP release in cooperation with external QPs. - Provided QA expertise to cross-functional teams ensuring compliance with FDA, EU-GMP, and ICH guidelines. - Created and maintained Product Specification Files (PSF) and other GMP quality documentation. - Led GxP supplier qualification activities for the relevant programs. - Conducted external GMP audits as Lead Auditor. - Supported analytical method tech transfer. - Enabled the initial Phase III clinical trial supply through cross-functional coordination of DS/DP intermediate and IMP release activities with external QPs. - Achieved cost savings of approximately 200,000 EUR through external audit process optimization.
- Managed GMP-compliance across manufacturing operations, enabling successful FDA and EMA submissions for biosimilars Ustekinumab and Aflibercept. - Quality Lead for two parallel biosimilar projects, covering Quality CMC through to commercial for drug substance (DS), bulk drug product (DP), and secondary packaging activities at CMOs across the EU and USA. - Managed process validation (PPQ) and analytical method validation (acc. to ICH) in collaboration with subject matter experts (SMEs), including tech transfer activities. - Reviewed and approved GMP- and CMC-related documentation, including release specifications, justification of specifications, master batch records (MBR), electronic batch records (eBR), deviations, and change controls. - Acted as primary QA contact for external Qualified Persons (QPs) and external partners. - Negotiated and drafted quality assurance agreements (QAAs) with CMOs and critical GMP vendors. - Conducted GMP self-inspections and external GMP audits as a co-auditor. - Established a risk-based supplier qualification process in accordance with GMP guidelines. - Improved QMS efficiency by reducing the backlog of external deviations and change controls by approximately 25%.
- Led the packaging validation project, supporting successful MFDS (South Korea) import inspection and approval. - Provided QA oversight for GMP-compliant production and packaging operations. - Managed qualification activities (DQ/IQ/OQ/PQ) and process validation (PPQ/CPV). - Managed deviations, CAPAs, and change controls. - Conducted GMP training sessions with a focus on Data Integrity (DI). - Acted as primary QA contact for the Qualified Person (QP), Production, Engineering, QC, and external Partners to resolve operational topics. - Core team member for national and international health authority inspections (e.g., MFDS, South Korea). - Applied Lean methodologies to optimize and standardize equipment cleaning processes in the filling area, reducing set-up time and improving operational efficiency.
- Managed and continuously improved the GMP-compliant quality management system (QMS). - Reviewed and approved GMP documentation, including master batch records, executed batch records (eBR), SOPs, qualification and validation documents, and manufacturing instruction. - Established supplier qualification process and drafted standard quality assurance agreements (QAAs). - Quality Lead for inspection readiness, validation and qualification (DQ/FAT/SAT/IQ/OQ/PQ), deviation/CAPA management, change control, and internal/external audits.
Established and implemented a new GMP-compliant pharmaceutical quality management system (QMS) in a start-up environment, enabling initial GMP certification for Lutetium-177 (n.c.a.) radiopharmaceutical production.
Executed successful scale-up and process technology transfer of the upstream process (USP) for GMP manufacturing of the bispecific monoclonal antibody Ertumaxomab (IMP).