Kammersrohr, Solothurn, Switzerland
Highly motivated Life sciences professional. Leader with proven track record, - passion about Verfahrenstechnik, process, data, people and professional and personal development. Driven by purpose. Constant learner. Ready to inspire. Growth mindset. Ignites insights. Excels in leading and managing teams. Unwavering standards. Detective of truth and justice. Cross cultural. Good active listener. Presence. Intuitive. Astute observer. Leads by example. Connection builder. Data driven. Effective decision maker. favorite quote: Per aspera ad astra. Mit mehr als einer Dekade extensiver Industrieerfahrung und als passionierte Führungskraft bei Bioconjugates Operations Teamleader bei Lonza AG, leite ich ein Team, dass sich auf GMP-konforme Dokumentation und Batch Record Review für Bioprozesse konzentriert. Es besteht sowohl aus Bioprozessingeneuren und Batch Record Reviewern. Mit einem Masterabschluss in Lebensmitteltechnologie und -wirtschaft von der Fachhochschule Trier bringe ich fundierte technologische Kenntnisse und Führungsqualitäten ein, um Qualität, Sicherheit und Lieferstandards sicherzustellen. Meine Arbeit umfasst die Leitung von interdisziplinären Teams, die Organisation von Prozessdokumentationen und die Unterstützung bei Audits und regulatorischen Anforderungen. Mit Erfahrung in Changemanagement und LIMS, MES syncade und Delta V setze ich mich dafür ein, Prozesse kontinuierlich zu optimieren und die Zusammenarbeit zwischen Abteilungen zu fördern.
Management responsibility: 15 employees Build and led an efficient and cohesive team with Bioprocessengineers and Batch Record Reviewers Resonsible for budget and organisation of operations drug/ADC manufacturing focused on review for related documentation. Design of the international team. Decision maker in his area. Provide guidance and supports with technical and process specific trainings. Organisation of the review from Master Batch records, paper electronic ones, Bill of materials, Process parameter list and recipes. Participation in interdepartmental meetings and alignments with QA .Supoorting performing of records such as deviations, change controls, CAPAs, investigations, effectiveness checks and extensions in line with valid SOPs.Authors, reviews and approve GMP-relevant documents in the ownership of operations. Accountable regards safety , quality and delivery in his unit. decision maker in his area and steering the hiring process for his team. Representing in the operational area in customer meetings, audits and regulatory inspections. achievements: - Building an alinged, harmonized and cohesive and efficient team of Bioprocess engineers and Batch record reviewers. - Sicherstellung von Datenintegrität - GMP compliance - Abweichungen systematisch identifiziert - Schafft Entscheidungsgrundlagen fur Freigaben - Regulatorische Inspektion
Management responsibility: 12 employees Responsible for Operations drug/vaccine manufacturing focused on documentation. CAPAs SME. Decisionmaker in his area. Provide guidance and supports with technical and process specific trainings. Organisation of the review from Master Batch records, paper electronic ones, Bill of materials, Process parameter list and recipes. Participation in interdepartmental meetings and alignments with QA .Supoorting performing of records such as deviations, change controls, investigations, effectiveness checks and extensions in line with valid SOPs.Authors, reviews and approve GMP-relevant documents in the ownership of operations. Accountable regards safety , quality and delivery in his unit. decision maker in his area and steering the hiring process for his team. Representing in the operational area in customer meetings, audits and regulatory inspections. achievements: -Implementierung klarer Governance-Strukturen Im Batch-Release-Prozess zur Erhoehung von Transparenz, Entscheidungsqualitaet und regulatorischer Robustheit. Project leader for the BRR Harmonisation requirement from an global quality level. An aligned KPI tracker was implemented and as a base for Qaliser. - As project leader I managed additional on top of daily buisness an international project team from all running biologics projects successfully affecting all projects on an over 5000 employee site until successfull implementation. - Building an aligned, harmonized, efficient and cohesive team.
Project mRNA with Lonza AG Visp - GMP Batch Record Review consultant. Promoted into Senior Batch Record Reviewer. Promoted into Teamleader.
Management responsibility: 70 employees Responseabillities leading the production of supplemets, dietic foods and medical products in dosage form of capsules, pills and powder mixtures and sterile liquids. Personnel and production planning and full responsibility for the smooth running of those departments: production, warehouse and aseptic filling and packaging. Project management skills and staff training and supervision, key performance indicators and efficiency. Preparation of production documents, statistics, compliance with occupational safety, hygiene and maintenance schedules. Active troubleshooting and prevention. archievments: - machine park approx.50% enlarged
Responsible for the QMS. Project management and full responsibility of site wide preparation, implementation and monitoring of english unannounced -FDA,- IFS, customer-audits. Implementation and maintenance of the following standards IFS food, BRC, HACCP, GMP+. Creation of risk analysis and ensuring product safety and hygiene monitoring. Training of employees and complaintmanagement and handling of pest control.
Germ reduction in various pharma and food industries via technical implementation of pneumatic or ultra sonic modules and dispersing of API. Responsible for Project management and cold aquise with consulting and presentation with big industry customers. Planning execution of process engineering and plant tests. Hygienic and climatic plant status analysis. Microbiological laboratory activities and technical authoring.