William C. Email & Phone Number

Round Lake, Illinois, United States

• Perform instrumental particle analysis on various product profiles.• Independently test, troubleshoot equipment, and support the coordination of lab maintenance to ensure all deadlines are met.• Testing support for investigations and authoring lab testing exceptions.• Maintained data integrity and ensured compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations.

North Chicago

• Supported AbbVie drug substance/product pipeline (Stage 1 Discovery and Development) with a diverse cross functional team.• Performed analytical Method Development and Validation • Trained in Atlas instrument software.• Independently setup and troubleshoot for GC (6890, 7890) and Agilent HPLCs (1100,1200, and 1260)

Alsip Il

• Qualified 20 Raw Materials and consumable sources as part of a team to minimize disruptions in our supply chain.• Formulate at Lab scale to determine process viability and formulate at Plant scale with compounders.• Support products with Stability Testing, write reports, and author Change Controls• Updated manufacturing documents, acceptance specifications, and formulation documents• Perform QC tests such as Tinfoil Substitutes, Alginates, and Surgical Dressings to support method transfer activities.• Product Complaints – Assigned to investigate and resolve process and product complaints in a timely manner.• Augmented the current 5S procedure to improve scores (Auditor and 5S Lab Leader).

• Assisted in the remediation of >10,000 chemistry gaps found during a test method assessment.• Assigned as a technical writer of white papers to review, research and interpret technical documents.• Aligned corporate and regulatory to initiate gap remediation.

• Independently prepared, developed, tested and interpreted sample results for HPLC and GC/HS analysis as part of Stage 1 drug development.

Round Lake, Il

• Provided support for the Nanoedge Technology for formulating a poorly water-soluble drug into a stable parenteral as part of a Phase 1 Clinical Study• Independently managed and served as study director for developmental, preclinical, and clinical stability studies.• Developed and performed the testing for three novel procedures to characterize the physical properties of drug suspension with respect to re-suspensibility, filterability, and particulate matter determination. Extensively trained internally in characterizing drug suspensions by compound and stereomicroscopy.• Participated in weekly project team meetings and client review meetings. Presented work both internally and externally.Preparation and participation in a variety of protocols, interim reports, final reports, and final product specifications to support the ongoing stability studies.

Mount Prospect ,Il

• As part of a team, setup three instruments (LC/MS/ELSD) and developed methods that supported a 10-month quantitative stability analysis of 60,000 samples for a drug metabolite study.• Managed 20+ instruments in the Biosciences Division emphasizing troubleshooting of HPLC, GC, and LC/MS equipment.• Developed methods and setup analytical equipment for scientists utilizing background in HPLC for early toxicological and preclinical evaluations.• Designed and implemented a time efficient calibration and preventive maintenance procedure for the analytical HPLC equipment demonstrating $50,000 savings and a 50% reduction in instrument repairs.

Mount Prospect Il

• Coordinated analytical support for scale-up of raw materials used in new sweetener process to meet tight project deadlines.• Organized the analytical technology transfer for manufacture of raw material to ensure our toilers understood the analytical needs of the project.• Transferred analytical methodology and equipment (Gas Chromatography, Sulfur Chemiluminescence Detection) to major Toiler for training three analysts.• Presented monthly talks on analytical findings at departmental groups.• Supervised analysts in instrument training, data analysis, data interpretation and documentation• Validated methods for sweetener intermediates and final product per FDA requirements.• Co-developed a program to characterize reference standards in support of sweetener projects that resulted in approval of a second-generation sweetener.• Modified numerous existing HPLC methods and developed new GC methods to separate impurities in the standards.• Collaborated with the group leader to establish proper training programs, standard operating procedures for documentation and laboratory practices within department.• Supervised environmental chambers for ongoing GLP sweetener stability studies to help secure approval for a second-generation sweetener.

Bachelor’S Degree, Chemistry

Master Of Business Administration - Mba