Juergen Schmickler
Manager Manufacturing Operations USP
Experience
Jan 2024 - Dec 2024
1 yearLengnau, Switzerland
Manager Manufacturing Operations USP
Thermo Fisher Scientific (TFS)
- CAPEX/Greenfield, 5kL SUT Owner, CVQ, Runs/PPQ, Op-Readiness, RM, Audits, Doc/Author, etc.
Jan 2023 - Dec 2023
1 yearMuttenz, Switzerland
Senior Consultant / Senior Coacher IMS
Getec Swiss
- Readiness/Optimization, Audits, re-certification IMS, GMP, ISO 9001, 14001, 45001, 50001, etc.
Jan 2023 - Dec 2023
1 yearWasserburg am Inn, Germany
Head of Sterile Production/Acting Head AMWHV (interim)
Recipharm
- Construction & CAPEX (Lead > 100 FTE), F&F, Lyo, Products releases, FDA, Annex1, Lean, FDA, CQV, EHS, etc.
Jan 2021 - Dec 2022
2 yearsVisp, Switzerland
Senior Consultant QC and VI DP Fill & Finish
Lonza
- CAPEX/IBEX, VI/Knapp/AQL, CQV, MES, CCS, etc.
Jan 2021 - Dec 2021
1 yearLinz, Austria
Senior Consultant CAPEX F&F (cGMP/GMP)
Takeda
- Optimization, compliance, auditing, training, etc.
Jan 2020 - Dec 2020
1 yearLeverkusen, Germany
Head of Operations (interim) Fill & Finish (start-up)
WuXi Biologics
- Construction OpEx & CAPEX (lead > 30 FTE, 80 Mill., site/OpEx lead), FDA, MES, CQV, audits, etc.
Jan 2019 - Dec 2019
1 yearTrittau, Germany
Head of Manufacturing/Acting Head AMG/AMWHV (interim)
Panpharma
- Board Member/BU lead (> 180 FTE, site), aseptic F&F, releases, CQV/mediafill, audits, EHS, etc.
Jan 2018 - Dec 2019
2 yearsRankweil, Austria
Head of Team Filling Solutions (interim) (start-up)
Rentschler/RFS
- Construction (lead > 40 FTE), cGMP, OpEx, RABS/Lyo, Asept. Program, CQV, MES, audits, EHS, etc.
Jan 2017 - Dec 2018
2 yearsMainz, Germany
Senior Consultant fill & finish/VI (start-up)
BioNTech
- Construction VI/Knapp, CQV, RABS systems, USP/DSP, cGMP/GMP, mRNA/vaccines, audit, etc.
Jan 2016 - Dec 2017
2 yearsFreiburg im Breisgau, Germany
Head QMB/Compliance Officer/RP 52a AMG (interim)
Alcon/Novartis
- QMS/QM (lead > 6 FTE), new ISO 13485, MDR/IVDR, 9001, 14971, GMP, transfer, audits, etc.
Jan 2016 - Dec 2016
1 yearSchorndorf, Germany
Deputy Head of Production, Acting Head AMG/AMWHV (interim)
Catalent
- Solida (lead 160 FTE), Compliance Officer, lead FDA readiness/audit, BRR, MES, CQV, EHS, etc.
Jan 2015 - Present
10 years 7 monthsEntrepreneur and Senior Expert
ex.bros swiss Schmickler
Jan 2014 - Dec 2015
2 yearsGermany
Head of Quality / Corporate Quality (interim) & QP
Acino Pharma
- Board Member/BU lead (global, > 150 FTE), construction Q-Corporate, site transfer (ca. 80 Mill CAPEX), QMS, CQV, releases, audits, EHS, etc.
Jan 2013 - Dec 2014
2 yearsBasel, Switzerland
QA Manager P-Technique & delegated QP/FvP
Roche
- O-Oversight, IMP CQV (URS, DQ-PQ, PPQ, ECC, etc) of API/commercial/aseptic filling, analytics, cGMP/GMP, FDA Readiness, RA/FMEA, audits, etc.
Jan 2011 - Dec 2013
3 yearsUnterach am Attersee, Austria
Senior Consultant/Projects/QA&QC/Production
Sandoz
- PL SELS, FDA inspections, QMS/SOPs, DEV/CAPA/CC/Compl., RM, CQV, RABS/USP/DSP, transfer, etc.
Jan 2011 - Dec 2012
2 yearsBaar, Switzerland
Senior QA Manager & QP/FvP (interim)
J&J/Janssen-Cilag
- QA Lead (6 FTE), BRR/QP-releases, PQR, cGMP/GMP/GDP, CAPA/RM, QMS, audits, trainings, etc.
Jan 2009 - Dec 2010
2 yearsMannheim, Germany
Site Head EHS (interim) & Compliance Officer
Alstom
- Site Board Member/EHS (lead 8 FTE), EHS compliance, SCC/14001/18001, RM, EHS audits, trainings, Excellence Road Map, etc.
Jan 2004 - Present
21 years 7 monthsFreelance / Senior Subject Matter Expert (SME)
Jan 2004 - Dec 2008
5 yearsIndependent SME, Project Manager & Senior Advisor, QMB/IMS (interim), Lead Auditor, Trainer
- Led projects in areas such as chemical parks, IMS/QMS/QA/QC, REACH, EHS, EFQM, cGMP/GMP, and audits.
- Clients included: dalli, Cognis, Jowat, Martinswerk, Ineos, Fresenius, P&G, Cosmopolitain Cosmetics, Mäurer, EU Commission, Hüttenes Albertus, Deutsche Steinkohle, Johnson & Johnson, etc.
Jan 1998 - Dec 2004
7 yearsVCI Executive Referent, Senior Project Manager & Advisor and Senior Trainer
Association Chemical Industry (VCI NRW)
- Responsibilities included: representative, production, EHS/GMP, IMS/QMS systems & audits, REACH, PM chemical park, etc.
- Clients included: VCI Chemistry/Pharma/MedTech, start-ups, chemical parks, BDI/IHKs/BG Chemie, etc.
Jan 1993 - Dec 1998
6 yearsConsultant, Lead Project Manager, Coacher, Trainer, Lead Auditor
Dr. Adams & Partner Unternehmensberatung
- Responsibilities included: construction, QMS/EHS-MS/IMS, lead audits, safety organizations, ASCA, certifications, etc.
- Clients included: Hoechst/HMR, Bayer, Celanese, Ticona, Degussa, Dr. Oetker, DB, GEA, G+H Isover, etc.
Jan 1990 - Dec 1992
3 yearsCologne, Germany
Head Production and Purchasing
Inorganic Institute, University Cologne
Summary
As a chemist, SME, interim manager, senior consultant, lead auditor, and trainer, I have extensive experience in pharma, biotech, medtech, and chemistry since 1993. My key competences are
- Manufacturing / Operations
- Quality
- EHS My competences in leadership, analysis, problem-solving, teamwork, and my soft skills have been the basis for my successful projects and roles at, among others, global players, start-ups, mid-sized companies, MAH/CDMO, and chemical parks.
Languages
German
NativeEnglish
Advanced Education
Oct 1990 - Jun 1992
University of Cologne
Dr. rer. nat., Life Science · Chemistry · Cologne, Germany
Oct 1981 - Jun 1990
University of Cologne
Master Chemist · Chemistry · Cologne, Germany
Oct 1971 - Jun 1980
Dreikönigsgymnasium
High School Diploma · Cologne, Germany
...and 1 more
Certifications & licenses
New ISO 13485, MDR/IVDR
Referent FDA Q-Oversight
Concept Heidelberg
QP/FvP Pharma/BioTech
Konzept Heidelberg
PM & Senior Trainer Chemical Parks
BG Chemie
Only Representative
SME REACH
SME TÜV VAwS
Senior Lead Auditor (ISO, GMP/FDA, EHS, QMS, etc.)
EOQ Auditor & Manager
TGA EHS Auditor
DGQ Professional Auditor
GMP Auditor
SME QMS
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