Jon Hesser Email & Phone Number

Richmond, Ca, Us

• Responsible for QC release and stability testing, method qualification and validation activities at my company's European CMO• Manage drug substance and drug product stability programs at same CMO• Personally review all lot release and stability testing results for clinical stage oncolytic virus• Collaborate with SillaJen and CMO QA departments to write / edit both internal and external deviations.• Compose analytical and stability sections for international regulatory filings (IMPD, IND, etc.)• Accomplishment: Immediately upon hire, worked cross functionally to manage successful completion of 11 bioassay method qualifications in four months at our CMO to prepare for IND filing.

Leverkusen, North Rhine-Westphalia, De

• Responsible for daily operations of a GMP Quality Control analytical chemistry lab• Manage up to 6 direct reports• Compose weekly schedule for lab testing and supporting activities• Guide lab investigations into deviations and invalid results• Manage instrument and equipment qualifications; method transfers and validations• Conduct periodic method reviews to identify and remediate validation gaps• Work cross functionally with other QC departments

Emeryville, Ca, Us

• Managed clinical stage appropriate method development and validations as well as method transfers according to ICH guidelines both in-house and at GMP CROs. • Managed lot release testing and stability studies for a drug substance and drug products.• Composed specifications for a drug substance and drug products.• Composed the CMC section for INDs.• Characterized / Qualified reference standards.• Trained research associates on HPLC use, maintenance, and troubleshooting.

Emeryville, California, Us

• Developed methods for protein characterization of monoclonal antibodies, antibody Fabs, and peptides using HPLC and LC-MS.• Performed test methods under current GMPs for release of toxicological and Phase I clinical materials.• Developed and characterized tryptic map methods for full-length antibodies and antibody Fabs.• Supported the Cell Line and Media Development group by developing a RP-HPLC titer method to analyze a secreted protein level in media samples.• Supported Process Development by analyzing intact antibodies and antibody fragments using MALDI-TOF to determine product consistency between productions lots and purification steps.• Developed an LC-MS purity and identity method for a peptide product. Later, modified this method to measure titer for toxicology material release.

• Performed CHNS (carbon, hydrogen, nitrogen, and sulfur) and bomb calorimetry experiments on coal, coke, and oil samples.• Determined total particulate levels from fuel cell coolant streams.• Updated the Laboratory Information System (LIMS) database keeping sample results current and accessible.

• Managed and trained two chemists on test methods and cGLP testing requirements.• Performed QC testing (HPLC, GC, KF, IR) to release final products and raw materials.• Composed SOPs and final product CoAs.• Maintained GLP chemical, reagent, and equipment logs.• Performed instrument preventative maintenance and repairs.