Dr. Jörg Plugge

Transfer/Analytics/Inhalation and CMC Project Expert Combination Products

- 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

- 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

- 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

- 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

- 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

- Lab-scale experiments for soil/water/plant systems; GC-MS and 14C trace analysis