BUS. Cit. // N.J. RESIDENT // NO RELOCATION AVAILABILITY
BS Chemistry, AAS Chemistry
Tablets, semi-solids, polymers, microemulsions, injectables, topicals, including controlled substances // Tablet presses, spray coaters, high shear granulators, fluid bed driers, spray driers, Benchtop blistering, blenders and mills. // Instrumentation: fiber-optic (UV-Vis) dissolution, viscometry, osmolarity
Formulation development through manufacturing
Center for Professional Advancement
Formulation Design & Troubleshooting of Pharmaceutical Tablets, 2014
Microencapsulation & Particle Coating, 2011
Company Mentoring Program, 2013
AAPS Arden Conference 2013
Colorcon Modified Release Forum, 2011
Brookfield Rheology / Methodology Seminar, 2003
ACS Short Courses
Essentials of Medicinal Chemistry and Pharmacology, 2007
Advanced HPLC in Pharmaceutical Dosage forms, 2006
Pharmacology for Chemists, 1992
Practical HPLC Method Development, 1992
Tamper Resistant Pharmaceutical Formulations US Patent Application
Abuse Deterrent Dosage Forms Non-Provisional Patent Application
“Benzimidazole non-aqueous compositions”, issued March 30, 2010
“Gel compositions for control of ecto-parasites”, issued July 6, 2010
2011 – Present
Senior Scientist 2014 – Present
Lead Formulator on CMC team preparing for FDA submission. Collaborate across departments ensuring all facets of project are on target. Lead new project through development and scale-up.
Lead project by manufacturing pilot scale batches, evaluating stability, and preparing documentation and supplies, meeting Phase I clinical trial timelines.
Supported lead scientist on polymer-based product by manufacturing, performing dissolution, and conducting experiments, meeting timeline to initiate clinical trial.
Scientist 2011 – 2014
Researched new abuse deterrent / tamper resistant ideas and solid dosage form projects. Partnered with team members on projects by manufacturing materials under cGMPs.
Demonstrated success as lead formulator on project, conducted experiments using QbD, stability studies, and scaled up to manufacturing. Co-inventor on patent for project due to selection of key excipient, resulting in promotion from Scientist to Senior Scientist.
Compiled and interpreted data to compose Pharmaceutical Development Report, supporting New Drug Application.
Planned and executed in-vitro abuse liability testing with analytical team, providing data for strong patent application.
Collaborated with lead formulator on Phase III project, gaining experience with manufacturing, compression coat, spray coating, and tablet printing at manufacturing site.
Communicated and coordinated with Regulatory Affairs, Medical Research, and Contract Clinical trial site in successful Phase I clinical trial. Succeeded in writing pharmacy manuals, instructing pharmacists on procedures, and ensuring prompt delivery of supplies and equipment.
Submitted abuse deterrent formulation for new IP. Conducted experiments supporting technology and patent application with input from Patent Attorney. IP submitted Q1 2014.
2005 – 2010 Scientist I-III
Formulated oral, topical, and injectable anti-parasitic dosage forms for discovery and pre-clinical trials. Consistently demonstrated ability to learn new tasks quickly and efficiently.
Manufactured small scale clinical batches under cGMP’s, gaining knowledge in all facets of formulation development.
Collaborated with lead scientist in formulating non-aqueous injectable and novel Self-emulsifying Microemulsions Drug Delivery System (SMEDDS) formulation. Both were approved and marketed.
Provided analytical support including HPLC method development for discovery projects utilizing various APIs. Increased productivity by quick turn around on results and determining whether to move forward.
Facilitated monthly safety meetings as Safety Coordinator, lab inspections, and authored job hazard analyses for equipment and processes, which contributed to meeting site’s OSHA requirements.
Scientific Assistant – Senior Scientific Associate 1987 – 2005
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