Dr. Jörg Plugge
Angestellt, Product Technical Director / Principal Scientist, AstraZeneca
Bad Homburg, Deutschland
Werdegang
Berufserfahrung von Jörg Plugge
Bis heute 5 Jahre und 11 Monate, seit Aug. 2018
Product Technical Director / Principal Scientist
AstraZeneca
- As Technical Product Steward supporting life cycle management and late-stage development for combination products (inhalation) - As analytical expert supporting method optimization, validation, transfer and monitoring for combination products and aseptic capsules - Expert in integrated technology transfer, analytical methods life-cycle management, and extractables and leachables - Supporting QC, QA and audits - Lead advisor for systematic problem solving and lean leader with lean academy graduation
3 Jahre und 9 Monate, Nov. 2014 - Juli 2018
Head of Laboratory, Product Development
Sofotec GmbH – a member of the AstraZeneca Group
- Coordinated stability, characterization and special studies for drug product development - Provided control strategy for a new combination product for the US market - Performed life cycle management including process robustness monitoring for marketed inhalation product - Provided technical expertise for business continuity plans, change controls, and risk assessments - Supervised problem solving for EU/US market production - Managed a HPLC team of six people and responsible for CMC Analytics Late Phase
5 Jahre und 7 Monate, Apr. 2009 - Okt. 2014
Laboratory Manager Late Phase Development
Almirall Sofotec GmbH, Bad Homburg, Germany
- Designed and responsible for stability and combination product characterization studies - Supported control strategies and analytical method transfers - Managed a HPLC team of nine people and responsible for CMC Analytics Late Phase - Provided technical expertise to CMC teams for drug product development from clinical phase II up to technology transfer to manufacturing sites; reporting to external partners and upper management - Compiled CMC dossiers for clinical studies and market authorizations
3 Jahre und 7 Monate, Sep. 2005 - März 2009
Head Analytical Chemistry
Almirall Sofotec GmbH, Bad Homburg, Germany
- Responsible for quality control acc. to GMP/international guidance for starting materials/excipients - Managed a team of four people for instrumental analysis (GC-MS, HPLC(-MS), laser diffraction) - Coordinated contract research organization (CRO) laboratories and supporting CRO audits - Supported drug substances and excipients second supplier evaluations and audits - Designed and supervised extractables and leachables studies for devices - Leaded a development program for an inhalation grade lactose
3 Jahre und 8 Monate, Dez. 2001 - Juli 2005
Laboratory Manager
IBL Umwelt- und Biotechnik GmbH, Heidelberg, Germany
- Managed a team of four people for environmental analytics (GC-MS, HPLC, ICP-MS, PCR) - Provided project management for internal and external projects - Supported project acquisition, customer services, and controlling - Responsible for expertise reports and quality control
1 Jahr und 1 Monat, Nov. 2000 - Nov. 2001
Leading research associate DFG
ZALF e.V., Müncheberg, Germany
- Lab-scale experiments for soil/water/plant systems; GC-MS and 14C trace analysis
Ausbildung von Jörg Plugge
1996 - 2001
PhD in Chemistry / Additional degree in Toxicology (Postgraduate Studies, Medical Department)
University Leipzig, Germany
1995 - 1995
ERASMUS studies, Analytical Chemistry
Dublin City University, Dublin, Ireland
1993 - 1996
Master Degree in Chemistry
University Leipzig, Germany
1991 - 1993
Pre-degree in Chemistry
Carl v. Ossietzky University, Oldenburg, Germany
Sprachen
Deutsch
Muttersprache
Englisch
Fließend