Louis Sheehan, J.D., CPhT

**** ******** ******, ***. ****

Rancho Cucamonga, California 91730

717-***-****

acy1w7@r.postjobfree.com

Linkedin: www.linkedin.com/in/louis0j0sheehan

Would relocate for the right opportunity.

SUMMARY

Segueing to a career in the Sciences.

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 Institute where I majored in Regulatory and Clinical Affairs and Quality Assurance.

Licensed by the Pennsylvania, D.C., and Maryland State Bars. I am a Pharmacy Technician, EMT, Phlebotomist and have taken courses in Surgical Technology and Nursing.

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

EMPLOYMENT

2015 – 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 WORK

Johns Hopkins Scholar.

National Merit Scholar.

WITF Public Broadcasting – Led Call Center for Smart Talk Television Program.

EDUCATION

Additional 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 2009-2011

B.S. in Biotechnology & Biosciences

Internship at Dauphin County Coroner’s Office

Magna Cum Laude GPA 3.89

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

Taxation

Johns Hopkins University Baltimore, MD 1978-1982

B.A. Social and Behavioral Sciences

SELECTED KGI COURSEWORK

Introduction 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.

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