Jason LePree
Vice President of Scientific Affairs at Elite Laboraties
Greater New York City AreaPharmaceuticals
Current
Elite Laboratories, Long Island University
Previous
Capsugel, Abon Pharmaceuticals LLC, Penwest Pharmaceuticals/Endo Pharmaceuticals Post Acquisition
Education
University of Wisconsin-Madison
446
connectionsSend a messageMore options
Relationship
Contact Info
Connected 2 months ago
Background
Experience
Vice President of Scientific Affairs
Elite Laboratories
September 2014 – Present (5 months)Northvale, NJ
Provide technical oversight for Analytical R&D, Formulation R&D and Quality Control.
Design, implement and oversee in-vitro challenge tests for abuse resistant narcotic formulations.
Design, implement and oversee pre-formulation studies to support development of immediate release and sustained release abuse resistant formulations.
Provide technical oversight for development of immediate release and sustained release abuse resistant formulations.
Program Director of Pharmaceutics and Adjunct Professor
Long Island University
1998 – Present (17 years)Hudson Graduate Campus, Orangeburg, NY
Instructor of graduate level courses: Pharmaceutical Analysis course and Physical Chemistry.
Program Director and Advisor (starting April, 2012)
I am responsible for student and faculty recruitment, student advisement, developing and authoring Outcomes Assessment Plans and Final Reports, and evaluation and redevelopment of Pharmaceutics Curriculum
Principal Scientist
Capsugel
July 2013 – September 2014 (1 year 3 months)Pearl River, NY (Site Closure Announcement October 2014)
Drug Delivery Technology Development
Use my prior experiences in Analytical Development, Preformulation and Non-solids formulations research to develop lipid-based dosage forms, including solid lipid particles, SMEDDS and SEDDS for administration in various formats including soft or hard capsules.
Formulations are developed for H&N (Nutraceutical) markets.
Abon Pharmaceuticals LLCResearch Fellow, Formulations Research and Development
Abon Pharmaceuticals LLC
April 2011 – August 2013 (2 years 5 months)Northvale NJ
• Develop formulation and processing steps for controlled release oral formulations
• Develop controlled release parenteral formulations
• Write documents for Regulatory submission including, Pharmaceutical Development, Quality Overall Summary and Quality Overall Summary, QBR for Sterility Assurance
• Use my pharmacy background to identify novel drug products for development.
Director, Preformulation and Non-solids Formulation
Penwest Pharmaceuticals/Endo Pharmaceuticals Post Acquisition
July 2007 – April 2011 (3 years 10 months)Patterson, NY
I am responsible for physical characterization of new chemical entities, including pKa determination, solid state stability, stability in solution, and solubility determinations and intrinsic dissolution testing using techniques such as HPLC and UV spectrophotometry and solid state characterization using modulated DSC, TGA and cross polarized hot stage light microscopy. In addition, I support all non-solids formulation development and manufacture for preclinical and clinical studies.
Key skills and accomplishments:
• Used lipolysis testing and other in-vitro tests to formulate and select lipid-based dosage formulations for preclinical studies, Phase I and Phase II studies for drug candidate, A0001. Became in-house expert in manufacture of liquid-filled hard gelatin and HPMC capsules.
• CMC team leader for drug development candidate and led a team of scientists including representatives from Analytical Sciences, Quality Assurance, Formulations, Non-solids, Quality Control, and a contract research organization to ensure drug substance and drug product were available for pre-clinical and clinical trials.
• Wrote the drug product and drug substance sections for the Phase I and Phase II INDs and Phase II IMPDs.
• Developed creams, ointments, and emulsions for development candidates for dermatological and rectal use. Verified physical and chemical stability of the topicals through stability studies.
(Open)1 recommendation
Saralena Martin
Saralena Martin
Librarian/Information Specialist
Jason is a very accomplished and innovative scientist who always finds ways to improve processes and get things done.View
NovartisResearch Fellow
Novartis
2006 – 2007 (1 year)
I supervised three scientists who assisted me in development and validation of methods for Assay and Impurity Analysis in support of two aggressive development programs.
Hoffmann-La RochePrincipal Scientist
Hoffmann-La Roche
January 2003 – August 2006 (3 years 8 months)
I developed and validated analytical methods for Assay and Impurity of drug products using HPLC and GC and dissolution methods tablets and capsules using both HPLC and UV spectrophotometry.
I was the first employee at Roche to earn Green Belt certification in Roche's Lean Six Sigma program.
Principal Scientist, Analytical Sciences
Boehringer Ingelheim Pharamceuticals
1998 – 2003 (5 years)
