Last update: 19.01.2024
(ca. 40 FTE) and Senior Consultant fill & finish, WuXi Biologics (CDMO)/ Astra Zeneca (MAH), site Chemical Park Leverkusen (D)
lead start-up & CAPEX project duty: construction and ramp-up managing operations, DSP/aseptic/sterile manufacturing (A-E), fill & finish/lyophilization/ isolator & RABS systems, vial-lines, media-fill strategy, cGMP/GMP readiness & compliance/21 CFR 210/211, CMC, products: vaccines, biologics, etc.
180 FTE, budget, 3 shifts, board member, BU: operation/production, packaging, engineering, technique, planning, storage, Rotexmedica (MAH/CMO), site Trittau (D)
lead commercial duty: managing manufacturing and operations, USP/DSP/aseptic/ sterile manufacturing (MSAT, A-E), fill & finish/RABS, ampule/injection/vial-lines, KPIs/RFT, releases, CAPEX project: combination line, maintenance/TGA/media-fill management, lean/shop floor/RM/FMEA management, EHS/cGMP/GMP compliance, RA/CMC, MASAT, products: biologics, anti-infectives, BTM, etc.
lead start-up & CAPEX project duty: construction and ramp-up managing fill & finish group, USP/DSP/aseptic/sterile manufacturing (A-E), fill & finish/lyophilization/RABS systems, vial-lines, media-fill, process validation, CMC, CAPEX project: construction (FDA) aseptic behavior & training, aseptic/sterile/biologics/API production, biotech-plants/equipment, implementation lean/shop floor management, batch bank, products: biologics, API, anti-infectives, vitamins, drugs, LM/peptides, etc.
lead CAPEX PM duty: USP/DSP/aseptic/sterile manufacturing (MSAT, A-D), MES process, fill & finish/RABS systems, vial-lines, media-fill, construction & organization visual inspection, Knapp qualification, cGMP/GMP compliance, biotech-plants/equipment, CMC, products: mRNA/RNA, LM/peptides, biologics, vaccines, oncology, etc.
lead commercial & CAPEX PM duty: construction QA, QMS integration ISO 13485/ 9001/MDR/IVDR/14971, lead site to site transfer pharma products, GMP/GDP compliance/21 CFR 820, integration lean management logistic/warehouse center, products: biologics, API, drugs, MDs (Cl. I-III)/IVDs, MDR/IVDR, chemicals, etc.
(160 FTE, 3 shifts, operation/production (C-E), engineering, technique, planning, BRR, storage), Catalent (CDMO), site Schorndorf (D)
lead commercial & PM duties: bulk manufacturing/plants/equipment, granulation/ extraction/coating systems, lead PM: FDA readiness/remediation program (PAI, preparation, etc.), KPI/RFT, process safety, lean/shop floor management, product transfers, process validation, organization batch bank, cGMP/GMP compliance, deviation/ CAPA/CC management, products: APIs, drugs, tablets, capsules, etc.
(ca. 150 FTE, cost/budget management, board member, Head BU: corporate & site QUs/QAs/QCs, pharma covigilance (PV), RM, QMS, Audit & Training system, GQRB, global/all sites, analytics/ laboratories), Acino Pharma (MAH/CDMO), site Aesch
lead commercial & CAPEX PM duty: accountable QMS and Q-standards/strategy, cGMP/GMP compliance, RA/CMC, quality on the floor, release management, RM/deviation/CAPA management, inspection/customer audits, lead PM: FDA feasibility study, site risk assessments/ICH Q9, site transfer program (products, plants/equipment, analytics), site decontamination program (penicillin derivates), lean/shop floor management and QC lean lab, construction & organization corporate quality, products: API, drug, penicillin derivates, OTCs, implants, etc.
site Basel (CH), Genentech, site San Francisco (USA)
lead commercial & CAPEX PM duty: responsible cGMP/GMP compliance and SOP/Q-standards, release qualifications / validations (CQV, ECC, URS, DQ-PQ, processes, utilities, facilities, HVAC, SAT, FAT, CE, testing), deviation/CAPA management, fill & finish (A-E), FDA readiness program, BRR, lead PM: turnaround & transfer clinical API to commercial, WBI/WFI/filling plants/ equipment, construction quality process management in USP/DSP/MSAT manufacturing/ quality on the floor, QP/releases, implementation RM/FMEA, products: IMP, R&D, LM/Biologics/ oncology, API/commercial, drugs (liquida/solida), etc.
lead commercial duty: QMS/SOP management, deviation/CAPA/change control and complaints management, quality on the floor, biotechnology/RABS systems, and USP/DSP (scale up) processes, fill & finish, responsible cGMP/GMP/GDP compliance, CMC, SOP/Q-standards, RM/FMEA management, CAPEX PM duty: lead rollout SELS & training BUs/BURs, lead site training deviation/trackwise, lead project underfillings, lead transfers (biologics/products, biotechnology), FDA inspection: PAI / post, products: LM/Biologics/Biosimilars, penicillin derivates, oncology, API/commercial, drugs (liquida/solida), etc.
(ca. 10 FTE, Executive Manager), Janssen Cilag / J&J (MAH), site (logistic/warehouse) Freiburg, Baar (CH)
lead commercial duty: QP/FvP releases, QMS/SOP management, deviation/CAPA/change control and complaints management, PQR management & releases, quality on the floor, logistic / warehouse systems & processes, responsible cGMP/GMP/GDP compliance, RM management, lead CAPEX PM duty: site to site transfer pharma products, training / personal qualification, products: LM/biologics/biosimilars, vaccines / blood preparates, oncology, drugs (liquida/solida), implants, cytostatic, OTCs, API/commercial, drugs, etc.
(ca. 8 FTE), Alstom, site Neumark
lead commercial duty: EHS releases, EHS compliance / system and management (EHS media, SCC, ISO 14001 / EMAS), SCC management / surveillance, contractor / obligation management, EHS construction site management, EHS audits & trainings, site risk assessments, lead CAPEX PM duty: implementation and ramp-up internal EHS excellence road map, incident / emergency management, products: construction pharma / chemical / power plants & equipment, etc.
Manufacturing & Quality (cGMP/GMP, EHS & ISO regulations and compliance, site QMS, etc.), lead strategical PM: chemical / industrial parks Germany (Bayer/Leverkusen, Infraserve Höchst/Knapsack/Kalle Albert, Wesseling, Infracor Marl, Infraleuna, Chemiepark Bitterfeld & Skopau, etc.)
Senior Advisor REACH, MDD/IVD (Kl I-III) and Quality Compliance & Only Representative, Fresenius, site Schweinfurt, Jowat, sites Detmold (D), Buchrain (CH), Ineos/Innovene, sites Dormagen (D) and Marl (D), dalli/Grünenthal, site Stolberg (D), Membrana, site Wuppertal (D), etc.
Quality Expert Recalls & Assessments, implementation QMS excellence (ISO 9001/EFQM), dalli / Grünenthal Pharma, site Stolberg (D)
QEHS Manager & Site Representative (ca. 15 FTE, GMP, ISO 9001 / EMAS / 14001 / SCC, etc.), CWS, site Düren (D)
REACH representative EU twinning projects and IHK, governments/enterprises, sites in Europe, USA, Asia, etc.
EHS expert & Senior Consultant EHS compliance / EHS management systems,
Lead Management System Board NRW (regulatory compliance and systems: QMS, cGMP/GMP, ISO 9001/13485, 14001/EMAS, ICH, inspections/audits, ca. SME leadership for 140 enterprises in NRW
manufacturing & quality (cGMP/GMP, EHS & ISO regulations and compliance, site QMS, etc.), lead PM duty: cGMP/GMP site and plant management, approval (authority) management, crises management, obligation systems & 52a BImSchG, § 5 (1) Nr. 3 BImSchG, Seveso 2, expert VAwS plants, etc., VCI members
Turnaround Hoechst (i.a. site risk assessments, management transfer products/plants/equipment, filling lines / fermenter / A-E, products: API, biologics, drugs, etc., manufacturing & quality (cGMP/GMP compliance, EHS & ISO regulations and compliance), Hoechst/HMR/Aventis, sites F-Höchst/Mainz/Griesheim, Celanese, site FFM, etc.
Implementation of Management & Legal Safety Systems (i.a. cGMP/GMP, QMS/ISO 9001, EHS regulations/EMAS/ISO 14001, Integrated Management system (IMS)), Hoechst, site FFM (D), Bayer, Leverkusen (D), BP/EC Erdölchemie/OMW, sites Dormagen (D), Karlsruhe (D), Dr. Oetker, site Budenheim (D), Deutsche Bahn, site Berlin (D), Frankfurt (D), GEA, site Stuttgart (D), etc.
Lead Auditing (ISO 9001, EHS Certifications), i.a. ASCA Program (ca. 120 enterprises & audits, FFM area), G+H Isover, LFK Lenkflugkörpersysteme, site Friedrichshafen (D), etc.
