Thomas (Tc) Coady Email & Phone Number

New York, Us

New York, Us

New York, Us

Raleigh, Nc, Us

Beginning in February 2022, I added QA to my prior QC role of building ground-up quality systems for commercial operations and overseeing analytical testing by third-party CDMOs. • Lead a team of four quality professionals to oversee analytical testing operations, batch release, supplier management and quality systems• Establish commercial cGMP systems and procedures• Conduct audits of service providers and negotiate quality agreements• Lead analytical aspects of site transfers for commercial products• Provide input for regulatory strategy, compile information, and author regulatory submissions

Raleigh, Nc, Us

Tokyo, Tokyo, Jp

Prior to Asahi Kasei’s acquisition of Veloxis, I performed batch record review, oversaw analytical testing operations, led investigations, and supported regulatory submissions. • Remediated the change control system, audited training files, and resolved gaps• Optimized tracking systems, which helped reduce the average turnaround time for batch record review from six months to two weeks

Billingham, Gb

Following my promotion from Associate Director, I managed a 45-member team to provide continuous support of microbiology, analytical, raw materials, stability testing, LIMS, and sample logistics management for 24/7 manufacturing operations. • Prepared for regulatory inspections by the FDA, MHRA, ANVISA, and PAI• Implemented a robust technical review process to ensure data integrity and reduce number of stability report revisions• Launched laboratory supply consumption tracker for an annual savings of $600K

Billingham, Gb

Bridgewater, N.J, Us

I managed international and domestic vendors who performed commercial release and stability testing for 23 commercial products, which cumulatively represented $1B in annual commercial sales. • Managed three QA/QC staff who evaluated analytical data• Led and oversaw investigations, assessed change controls for regulatory impact, and performed audits for qualification and routine surveillance to ensure compliance with GMP regulations• Managed a $5M department budget• Authored QC sections of annual product review reports and CMC sections for annual report regulatory filings• Evaluated, selected, and negotiated contracts and quality agreements with contract laboratories

Somerset, Nj, Us

I was fortunate to be recruited back to Catalent after Merck acquired Inspire in 2011. During this time, I managed five QA auditors to inspect for both GLP and cGMP compliance on a 400-employee site.

Rahway, New Jersey, Us

Prior to Inspire’s 2011 acquisition by Merck, I managed four domestic contract analytical testing laboratories, with responsibility for release and stability testing of commercial and R&D drug substances and drug products representing $40M in annual sales.• Directed three QA/QC staff and maintained oversight of up to 12 full-time equivalents at contract labs in the development, validation, and transfer of analytical procedures to contract facilities and evaluation of analytical data• Managed a $3M department budget• Authored annual product review sections and CMC sections for IND, NDA, and annual report regulatory filings• Evaluated, selected, and negotiated contracts with contract laboratories

Rahway, New Jersey, Us

Somerset, Nj, Us

I directed three teams with a combined 10 employees in the delivery of manufacturing support, method development and validation, and release/stability testing for inhalation products that generated up to $1.8M in annual revenue. • Developed new analytical methods and oversaw day-today testing to support formulation development of metered dose inhalers (MDI) and nebulized drug products• Reviewed and approved testing protocols and final reports, certificates of analysis, and stability reports• Developed cost estimates for customer-requested work proposals

Dublin, Oh, Us

I supervised a team of up to five chemists tasked with developing and validating methods for solid dose formulation, a new service offering, which included clinical release and stability. I oversaw routine testing of drug substances, intermediates, and drug products to support manufacturing of Phase I/II clinical trial supplies.