Bad Aibling, Bavaria, Germany
27 years experience in the pharmaceutical industry 16 years operational experience as Manager Quality Control Stability and release testing of active pharmaceutical ingredient (API) and clinical trial material (CTM) in a GMP environment Supplier qualification (full analyses of raw material and APIs, reduced testing) Manage, plan and direct the Quality Control laboratory to ensure timely lab testing and to provide the highest quality analytical support for manufacturing while ensuring compliance with protocols, GMP and safety regulations Leadership role for a team of 25 colleagues (4 Teamleads) 6 years operational experience in bioanalysis and pharmacokinetics of small molecule and antibodies in non-clinical and clinical studies Schedule study phases as GLP Study Director / Principal Investigator in coordination with the preclinical and clinical department Responsibility for preparation of bioanalytical study protocols and study reports in more than 30 GLP studies Experience in inspection by authorities (GLP) Preparation of pharmacokinetic reports Professional experience within a FDA- and EMA-regulated GxP environment Provide feedback to the relevant project teams on PK, PK/PD, bioanalysis and QC issues Strong experience in managing staff in a laboratory environment
Manage, plan and direct the Quality Control laboratory to ensure timely lab testing and to provide the highest quality analytical support for manufacturing while ensuring compliance with protocols, GMP and safety regulations. Leadership role for a team of 25 colleagues (4 Teamleads). Responsibility for the QC budget and the team development. Define personal and team development goals. Responsibility for ensuring compliance to GMP requirements, pharmacopeia and internal standards Establish appropriate specifications for raw materials and APIs and finished product in accordance with accepted standards. Direct the work activities of the raw material and finished product work groups to ensure that testing is executed in a timely and GMP compliant manner. Full analyses and reduced in-house testing of raw materials and APIs. Review and approve Certificates of Analysis, protocols and reports such as Method Validation, Method Transfer and Stability. Review and monitor action plans for correction of audit observations related to the Quality Control laboratory. Ensure all suppliers have been qualified and adhere to supplier qualification standards with the aim of optimal utilization of the reduced testing procedure Ensure that raw materials, APIs, labels and packaging materials conform to established standards of quality and/or purity Ensure that analytical equipment is adequately calibrated and qualified prior to use and continuously kept in a qualified state Establish and implement a KPI structure to ensure optimal test/cost ratio
Bioanalytical method validation according to EMA and FDA guidelines Pharmacokinetics, PKPD, Population PK, Modeling and Simulation Calculation and evaluation of pharmacokinetic parameters (non-compartmental and compartmental data evaluations). Data collection and report writing Study Director in GLP studies Bioanalytical measurements of samples (serum, plasma, tissue) from preclinical and clinical studies using LC-MS/MS and ELISA-techniques Organisation of biomarker analysis (uPA, PAI-1, CA IX) in a phase II study with a contract research organisation Technical and supervisory management of four employees Experience in inspection by authorities (GLP)
Bioanalytical method validation according to EMA and FDA guidelines (LC-MS/MS) Pharmacokinetics, compartmental modeling and simulation Calculation and evaluation of pharmacokinetic parameters (non-compartmental and compartmental data evaluations). Data collection and report writing Study Director in GLP studies Bioanalytical measurements of samples (serum, plasma, tissue) from preclinical and clinical studies using LC-MS/MS and ELISA-techniques Technical and supervisory management of four employees Experience in inspection by authorities
Development, optimisation and validation of stability indicating methods Stability and release testing of active pharmaceutical ingredient (API) and clinical trial material (CTM) in a GMP environment Dissolution and dissintegration of solid oral dosage forms, Karl Fischer water content determination, content of active ingredient, uniformity of content and weight testing of pharmaceuticals Assessment of deviations and out-of-specification (OOS) results Implementation of a quality assurance system GLP/GMP Technical and supervisory management of five employees