Christopher Kirchner Email & Phone Number

Southeast Asia

Managed analytical chemist team in the development, optimization, and qualification of oral and injectable drug product methods for early clinical trials; guided team in experimental setup, conclusion, and discussion with clients; resolved development issues alongside members on-site and remotely.Led team with first assignment in resolving critical non-deterministic robustness issue that suspended a project’s drug product development, overturning 4 months of prior conclusions with 2 weeks of work.Oversaw, trained, and evaluated analytical interns to bolster department personnel with new talent; Led intern in the development and presentation of assay, uniformity, and impurity methods for a microgram scale drug product, increasing method sensitivity by several orders of magnitude while resolving poor accuracy, reproducibility, and interference issues.Challenged traditional analytical thinking and processes globally; collaborated with international statistics group in fostering statistical concepts and improving experimental setup and conclusions across sites; co-authored and jointly executed evaluation protocol with overseas parties to automate impurity method development using artificial intelligence software.Proactively innovated dissolution development using in-situ UV analysis for real-time analysis and feedback, eliminating manual sampling and traditional LC determination, and increasing data points by three orders of magnitude while halving human operation time; successfully adapted current resources to new applications.

Greater San Diego Area

Oversaw analytical development and method optimization for novel drug product formulations with specialization for CDMOs; led development and validation of methods for dissolution, assay, and impurity analysis, tested for analytical development and quality control, troubleshooted issues with equipment, and partnered with clients to address technical issues.Led projects to develop and implement testing of new formulations for early phase clinical trials, utilized validated analytical methods to support development, and optimized blend uniformity methods to minimize variation. Managed validation and implementation of analytical software, developed SOPs for setup of software, instruments, and servers, installed and tested new systems, and resolved process, software, and hardware issues; successfully launched new systems and improved uptime and productivity. Developed and optimized impurity methods, including stability-indicating analysis of combination products using dual-wavelength detection to separate impurities, and large instrument-modified injection volumes to achieve sensitivity requirements for poor chromophores with good chromatography.Formulated in-vitro dissolution methods for new immediate and extended-release products with unstable, high-adsorbing, and low-solubility actives using HPLC and NPLC.Served as technical liaison to clients, reviewed analytical methods, executed analytical tests, provided real time updates on results, and addressed questions on method development decisions.Supported analysts in troubleshooting experiments and validating methods, reviewed processes to identify inconsistencies, analyzed results, and implemented fixes.Led installation of CAD detector with HPLC, authored qualification protocol, interfaced CAD server with Empower and LC, worked with vendor to execute qualifications and resolve issues.

San Diego

Led development of analytical methods and quality control tests to assess drug substance assay and purity; advanced unique methodology for quantitating drug substances and impurities, implemented new software solutions to improve data accuracy, and supported personnel in use and troubleshooting of software and instrumentation. Developed and executed methods for small-molecule pharmaceuticals under GMP requirements, and R&D synthetic chemistry and formulation for early to late phase clinical trials, established new methodology for quantitating drug substances and impurities using quantitative nuclear magnetic resonance (qNMR), enabled earlier insights into quality of drug substances for optimizing synthetic routes with better analytical data. Spearheaded computerization of analytical sample submission system, utilized MS SharePoint to automate analytical assignments, reminders, and results, coded visual programming interface, developed specialized ajax requests to REST API to query data not available through existing interface, and debugged electronic logging system in real time. Served as Empower administrator, created custom field calculations and report templates to meet SOPs.Resolved critical intermediate-precision and analytical-reproducibility issues affecting accuracy. Developed cleaning verification and novel visual determination techniques for GMP equipment to exclude time-intensive HPLC and sampling procedures.Supported OOS manufacturing investigation by identifying makeup of mislabeled filter material using HPLC-UV, MS, and NMR. Developed set of impurity methods to analyze API’s related substances with different chemistries.

La Jolla

Master'S Degree, Quantitative And Computational Finance

Data Mining & Statistical Learning, Numerical Methods in Finance, Derivative Securities, & Fixed Income Securities

Master Of Science - Ms, Computer Science, 4.0

Specialization in Computational Perception and Robotics: Artificial Intelligence, Reinforcement Learning, Machine Learning for Trading.

Bachelor'S Degree, Computer Science, 4.0

Discrete Math, Data Structures, Architecture & Assembly, Web Development, Algorithms, Databases, Operating Systems, Software Engineering.

Bachelor’S Degree, Biochemistry, Cum Laude

General Chemistry, Organic and Inorganic Chemistry, Physics, Physical Chemistry, Analytical Chemistry, Metabolic Biochemistry, Molecular.