Michael Goedecke, Ph.D. Email & Phone Number

Radnor, Pennsylvania, Us

Pharmacometrician• Developed population pharmacokinetic, PKPD, and exposure-response models for new drug products.• Analyzed pharmacometric data, interpreted results, performed QC reviews, and contributed to technical reports. • Contributed to modeling and simulation analysis plans for pharmacometrics projects.• Collaborated with pharmacologists, pharmacometricians, and statisticians to provide statistical advice as needed.Biostatistician• Produced tables, listings, and figures for statistical analyses of clinical trials.• Provided statistical support to clinical pharmacologists and pharmacometricians, particularly for bioequivalence studies, multivariate normal distribution sampling, and experimental design.• Produced content uniformity and dissolution acceptance limit tables for clients. Programmed calculation of dissolution acceptance limits for an extended release product.

Waltham, Ma, Us

Patheon is now part of Thermo Fisher Scientific.Applied Quality by Design principles and knowledge of ICH Quality guidelines, statistical and mathematical modeling, and experimental design to support process improvement in pharmaceutical product development and manufacturing.• Designed experiments, analyzed results, and optimized processes for new pharmaceutical products, including active pharmaceutical ingredients (APIs), oral solid dosages, and sterile injectables.• Analyzed pharmaceutical stability studies to determine shelf life for new products.• Explained and interpreted output of statistical and quantitative analyses to audiences with varied backgrounds.• Provided expert statistical and mathematical support, assisting internal customers with statistical questions.• Delivered scientific and statistical input for out-of-specification (OOS) and other investigations.• Authored statistical and technical reports as required.• Wrote and reviewed corporate guidelines and documentation. Developed training for statistical techniques.

• Wrote functional requirements, system design specifications, and IQ, OQ, and PQ test protocols for computer software validation, including for 21 CFR Part 11 compliance.• Designed, troubleshot, and validated Excel spreadsheets. Diagnosed and resolved spreadsheet problems.• Provided quality control review of statistical analysis plans.• Tested and documented software for internal and external customers.

Career break to pursue international adoption and integration of our daughter into our family.

Research Triangle Park, Nc, Us

Mathematical modeler and computer programmer. Built epidemiological models for the spread of infectious diseases. Modeled pharmacokinetic data. Built neural network.Specialties: stochastic models, mathematical biology, epidemiology, statistics, experimental design, multivariate analysis, AnyLogic, MATLAB, SAS JMP.

Developed sophisticated skills in biomathematics while studying stochastic modeling.Coached and taught students (as a teaching assistant) in various biomathematics and statistics classes.

Thousand Oaks, Ca, Us

Fermentation Research Associate (1994 - 1998):Designed, implemented, and analyzed experiments to develop microbial fermentation processes for new products and to improve processes and resolve technical issues for Commercial Manufacturing.Fermentation Manufacturing Associate (1989 - 1994):Executed microbial fermentation batches producing commercial drug product; validated equipment and processes; trained new fermentation personnel.Cell Culture Manufacturing Associate (1988 - 1989):Executed mammalian cell culture batches producing drug product for use in clinical trials; validated process equipment.

Ph.D., Biomathematics, With Statistics Minor

Bs, Biology