General management of laboratory operations in Wilson NC.

2016 - 2018 Focused on outward interaction with clients including setting up new studies and quoting work.2018 - Present: Focus on internal improvements in efficiency, expansion of service offering and management of non-routine projects.

Management of the chemistry and microbiology departments supporting contract testing for the pharmaceutical market.

Directed day to day laboratory operations to include determining extractables, developing and validating methods for analysis of leachables, conducting stability studies, testing container closure integrity, directing metrology, stability, project management and controlled substance programs. Managed staff of 15 to 25 laboratory scientists.• Partnered with management team to establish systems and subsequent analysis for nasal/inhalation products.• Implemented dual team concept to ensure continuity of work in absence of a team leader. • Identified need for and oversaw implementation of priority score to help clients make informed decisions about which analytes to study further.• Oversaw development and validation of more than 500 Methods.• Mapped out current state and future state process of both existing and acquired laboratories; developed action plans and implementation strategy to ensure cGMP compliance.

Recruited to manage day to day operations of an emerging cGMP Contract Laboratory and support Associate Director of Contract Laboratory Services.• Authored procedures for Instrument Quality Systems, Investigations, Reagents, Documentation of Data, Review and Reporting, Protocols, Guidelines for Validation, and various Instruments.• Established Practical Approaches and Method Development Guidelines.• Cooperatively established stability program, including study management qualification of chambers and establishment of monitoring program.

Supervised scientists performing stability projects for multiple clients and conducting maintenance/qualification of applicable instrumentation.Reviewed and approved out of trend/specification investigations.

Supervised scientists (B.S., M.S., Ph.D. level) who developed and validated methods supporting parenteral, tablets/capsules, creams/ointments and inhalation dosage forms for multiple clients. Reviewed and approved data and validation reports for scientific soundness and cGMP compliance.Evaluated requests for potential acceptance of work.

Supervised staff and responsible for up to 100 samples (1,000 tests) per day over two shifts.Analyzed facility water validation studies by wet chemistry and Total Organic Carbon (TOC) technologies. Organized results in audit ready format. Reviewed and approved data generated by department.Interviewed, hired and trained new employees.

Developed and validated new methods. Performed routine analysis of finished products, raw materials and stability studies using wide variety of instrumentation and wet chemical techniques.Served as Lab Safety Liaison.

Performed routine analysis of finished products, in process samples, stability studies and raw materials.Served as Lab Safety Liaison.