Louis Sheehan, J.D., CPhT9650 Milliken Avenue, Apt. 4107

Rancho Cucamonga, California 91730717.503.8335

Lsheeh14@students.kgi.eduLinkedin: www.linkedin.com/in/louis0j0sheehan

Would relocate for the right opportunity.

SUMMARYSegueing to a career in the Sciences.

More than two decades working in accounting, taxation (including two years for what was then Coopers & Lybrand and is now PricewaterhouseCoopers), ERISA/pensions, contracts, investments, divorces and medical malpractice.

More than a decade of work for three large pension funds creating partnerships and drafting contracts for investments in conjunction with venture capitalists and start-up companies. Examples of types of contracts: RFPs, NDAs, Private Equity, Pricing, Consulting, and Licensing.

More than a decade of medical malpractice and divorce work negotiating malpractice settlements typically in amounts exceeding $1,000,000.00 and divorce settlements of lesser amounts.

Exposed to the sciences while doing medical malpractice and thus motivated to return to school and earn a BS in Biotechnology (GPA 3.86) and, further, to earn a certificate in the Business of Bioscience at Keck Graduate.

Engaged on a contract basis to do Quality Consulting at expanding sterile compounding pharmacies for more than the past year.

Licensed by the Pennsylvania, D.C., and Maryland State Bars.

EMPLOYMENT2015 – Current Quality Consultant for GXP Consultants, Inc.

Project management of procurement and validation of GMP pharmaceutical equipment and related SOPs.

Provision of regulatory advice regarding decision to and method of registration of Compounding Sterile Pharmacy under 503B to ensure prompt review and approval.

Performed regulatory research relating to and monitored labeling of sterile human drug products under 503(B) in close cooperation with production staff.

Researched and communicated requirements to comply with FDA guidance relating to the use of bulk drug substances, repackaging, and adverse event reporting.

Ensured responses to FDA were complete and accurate. Reviewed batch records, risk management, correlation matrices, process characterization,

product stability reports, validation reports and trend analyses. Investigated patient complaints. Engaged in vendor and internal audits.

2000 – 2014 Attorney Investigated facts, monitored trials and negotiated settlements relating to medical

malpractice. Observed hundreds of surgeries and medical procedures and shadowed surgeons, physician assistants and nurses for hundreds of hours.

Negotiated divorce/QDRO issues relating to pension allocations.

1991 – 2000 Assistant Counsel, Public School Employees’ Retirement System (PSERS) Represented PSERS in administrative hearings and court appearances. My first case was

(successfully) concluded by Pennsylvania’s Supreme Court. Advised PSERS’ staff on issues and submitted numerous filings involving Trusts,

Guardianships, Wills, Severance Arrangements, POAs, taxes, accounting, debt collections, investment contracts, the IRS and the Pennsylvania Department of Revenue.

Accounting, auditing and tax background in what was then the ‘Big 8’. Examples of types of contracts: RFPs, NDAs, SOWs, Private Equity, Pricing, Consulting,

Licensing.

AWARDS & VOLUNTEER WORKJohns Hopkins Scholar.National Merit Scholar.WITF Public Broadcasting – Led Call Center for Smart Talk Television Program.

EDUCATIONAdditional Schools and Courses listed on Linkedin.

Keck Graduate Institute Claremont, California 2014–2015

Bioscience Certificate. Wrote Phase-II Clinical Trial SOPs, Protocols, and Budget for theoretical contraceptive. Led team for submission of mock IND application to FDA for Alicaforsen (drug for ulcerative

colitis). Analyzed in vitro glucose monitoring system for purposes of validation in accordance with

ISO 15197 Protocols. Reviewed Medtronic’s recently approved 510(k) for CRT-D Defibrillator assessment for new

indications.

Pharmacy Technician Certification 10054681; CA 143371.

Harrisburg University of Science and Technology Harrisburg, PA 2009-2011B.S. in Biotechnology & BiosciencesInternship at Dauphin County Coroner’s OfficeMagna Cum Laude GPA 3.89

University of Maryland School of Law, J.D. Baltimore, MD 1982-1985Taxation

Johns Hopkins University Baltimore, MD 1978-1982B.A. Social and Behavioral Sciences

SELECTED KGI COURSEWORKIntroduction to Food and Drug Laws and Regulations, Regulation of Drugs and Biologics, Clinical Trial Design, Conduct and Strategy, Medical Devices, In Vitro Diagnostics, Molecular Basis of Disease, Pharmaceutical Development, Bioscience Business (Excel-based course). Each class required at least one PowerPoint presentation.