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BENJAMIN N. NELSON 420 Harvey Avenue, Grayslake, IL 60030 224.571.3726 [email protected] www.linkedin.com/in/ben-nelson-pharmsci PHARMACEUTICAL SCIENTIST Self-Motivated Problem Solver with a Broad, Yet Sound, Scientific Background and Proven Record of Product Development Success Team-oriented problem solver with strong experience in pharmaceutical formulation, analytical chemistry, and separation sciences for small and large molecule drugs. Trusted leader meeting commitments with quality results. Advancer of projects through excellent understanding of pharmaceutical sciences, hard work, and quick learning. Build solid relationships with customers, peers, and team members from outside functionalities. Expertise in: QbD Formulation Development Equipment Procurement & Maintenance Process Development SOP, BMR Writing &Change Control Scale-Up & Exhibit Batch Manufacturing Technology Transfer cGxP Documentation Standards Team Development, Training & Mentoring PROFESSIONAL EXPERIENCE PFANSTIEHL INC., Waukegan, IL 2015 - 2016 Formulation Solutions Manager Conducted design of experiments (DOE) with statistical analysis. Presented seminars and webinars on formulation best practices to scientists worldwide. Led teams and managed timelines. Performed analytical method development. Generated project reports. Oversaw equipment procurement and maintenance. Interfaced with clients to solve lyophilized and liquid parenteral formulation issues, bolstering the company’s scientific reputation. Managed multiple formulation and process development projects ranging from excipient characterization, leading to process optimization and improved stability of a lyophilized parenteral formulation. Studied process unit operations and effect on product quality for 3 excipients, building project teams to conduct research. Presented scientific data at 5 onsite customer meetings and 3 conferences, receiving high marks on follow up questionnaires. Served as invited participant of Purdue LyoHUB consortium road mapping, providing novel ideas to guide future of lyophilizer instrumentation development. WOCKHARDT USA, Morton Grove, IL 2012 - 2015 Formulation Development Research Scientist Ensured proper cGxP documentation of entire R&D staff. Advanced projects through QbD product development. Transferred products to plant manufacturing. Supervised and mentored 2 associate scientists. Prepared scientific reports. Supported regulatory filings and audits. Ensured departmental compliance with drug enforcement administration (DEA). Performed wurster, topspray, and tablet coating. Led cross-functional teams and authored FDA question-based reviews (QBR) and chemistry and manufacturing controls (CMC) documentation for 9 products, resulting

Transcript of nelson_benjamin_n_resume_v01

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BENJAMIN N. NELSON420 Harvey Avenue, Grayslake, IL 60030 224.571.3726

[email protected] www.linkedin.com/in/ben-nelson-pharmsci

PHARMACEUTICAL SCIENTISTSelf-Motivated Problem Solver with a Broad, Yet Sound, Scientific Background and Proven

Record of Product Development SuccessTeam-oriented problem solver with strong experience in pharmaceutical formulation, analytical chemistry, and separation sciences for small and large molecule drugs. Trusted leader meeting commitments with quality results.

Advancer of projects through excellent understanding of pharmaceutical sciences, hard work, and quick learning. Build solid relationships with customers, peers, and team members from outside functionalities. Expertise in:

QbD Formulation Development Equipment Procurement & Maintenance Process Development SOP, BMR Writing &Change Control

Scale-Up & Exhibit Batch Manufacturing Technology Transfer cGxP Documentation Standards Team Development, Training & Mentoring

PROFESSIONAL EXPERIENCEPFANSTIEHL INC., Waukegan, IL 2015 - 2016Formulation Solutions ManagerConducted design of experiments (DOE) with statistical analysis. Presented seminars and webinars on formulation best practices to scientists worldwide. Led teams and managed timelines. Performed analytical method development. Generated project reports. Oversaw equipment procurement and maintenance. Interfaced with clients to solve lyophilized and liquid parenteral formulation issues, bolstering the company’s scientific reputation. Managed multiple formulation and process development projects ranging from excipient characterization, leading to process

optimization and improved stability of a lyophilized parenteral formulation. Studied process unit operations and effect on product quality for 3 excipients, building project teams to conduct research. Presented scientific data at 5 onsite customer meetings and 3 conferences, receiving high marks on follow up questionnaires.

Served as invited participant of Purdue LyoHUB consortium road mapping, providing novel ideas to guide future of lyophilizer instrumentation development.

WOCKHARDT USA, Morton Grove, IL 2012 - 2015Formulation Development Research ScientistEnsured proper cGxP documentation of entire R&D staff. Advanced projects through QbD product development. Transferred products to plant manufacturing. Supervised and mentored 2 associate scientists. Prepared scientific reports. Supported regulatory filings and audits. Ensured departmental compliance with drug enforcement administration (DEA). Performed wurster, topspray, and tablet coating. Led cross-functional teams and authored FDA question-based reviews (QBR) and chemistry and manufacturing controls

(CMC) documentation for 9 products, resulting in Food & Drug Administration (FDA)-accepted filings and 3 approved products with remaining pending approval.

Manufactured over 20 scale-up, exhibit, and clinical batches, completing in 3 years. Authored and/or reviewed over 100 protocols for exhibit, clinical, and scale-up batches, instrument and equipment

installation, operational, and process qualifications (IQ / OQ/ PQ), and raw material and component qualifications, advancing projects while following regulatory guidance.

UNIVERSITY OF KANSAS, Lawrence, KS 2012Post Graduate ResearcherConducted sample prepation and analysis. Led team scientific discussions. Developed novel analytical techniques. Performed protein expression, purification, and buffer exchange. Facilitated conference presentations. Mentored 2 graduate and 2 undergraduate students. Participated on collaborative project with industry partner, investigating monoclonal antibody formulation properties using

solution nuclear magnetic resonance (NMR). Analyzed novel monomers for suitability of use in dental polymers. Characterized physical and chemical properties of polymers and constituent monomers in various solvent systems, providing

new options for stronger, longer lasting dental implants.Benjamin N. Nelson [email protected] Page 2

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GENENTECH, South San Francisco, CA 2011Cooperative Internship in Monoclonal Antibody ResearchPerformed process and analytical development. Troubleshot and maintained instrumentation. Conducted sample, buffer, and reagent preparation. Generated data analysis and reports. Assisted associate scientists with projects. Produced oxidatively-stressed monoclonal antibodies for quantitative analysis and characterization on lab scale, saving large

amounts of expensive antibodies. Developed new and adapted existing analytical techniques, analyzing oxidation products of formulation properly and moving

project forward.

ABBOTT LABORATORIES, Abbott Park, IL 2007Internship in Global Formulation Sciences – Solids Gained pilot plant production experience, including attending all facility planning meetings. Coordinated acquisition of materials, laboratory space, and qualified assistants. Performed off-line analysis of samples, specifically near-infrared spectroscopy. Proved technique for on-line monitoring of tablet compression, completing first step in becoming base system for continuous

tablet manufacturing. Developed HPLC method for off-line testing of tablets, confirming results of online monitoring.

EDUCATIONDoctor of Philosophy (PhD), Pharmaceutical Chemistry

UNIVERSITY OF KANSAS, Lawrence, KSDissertation Title: Development of Multiple-Sample Solid-State NMR Probes for the Analysis of Pharmaceutical

Compounds and FormulationsResearch Advisor: Professor Eric J. Munson; Dissertation Chair: Professor Jennifer S. Laurence

Master of Science (MS), Physical ChemistryUNIVERSITY OF SOUTH DAKOTA, Vermillion, SD

Dissertation Title: Resonance Enhanced Multiphoton Ionization of Volatile Lanthanide Complexes with Mass Spectrometry Detection

Research Advisor: Professor Mary T. Berry

Bachelor of Science (BS), Natural Science, Emphasis: ChemistrySAINT NORBERT COLLEGE, De Pere, WI

AWARDS & HONORSMerck Pre-doctoral Fellow at University of Kansas in Pharmaceutical ChemistryMost Outstanding Graduate Student in Chemistry at University of South Dakota

PROFESSIONAL AFFILIATIONSAmerican Association of Pharmaceutical Scientists (AAPS)

American Chemical Society (ACS)

SELECTED PUBLICATIONS & PATENTSNelson, B. N.; Barich, D.H.; Munson, E. J. High-Throughput Systems for Magic-Angle Spinning Nuclear Magnetic Resonance.

U.S. Patent Serial No. 12/013,237.Laurence, J.S., Nelson, B., Ye, Q., Spencer, P. “Determination of neutralization capacity of basic methacrylate monomers in

mixed solvent systems using NMR”, Int. J. Polymer. Mater. 2013, 63, 361–367.Benjamin N. Nelson. Development of Multiple-Sample Solid-State NMR Probes for Analysis of Pharmaceutical Compounds and

Formulations. University of Kansas, Doctoral Dissertation, June 2011.Nelson, B. N.; Schieber, L. J.; Barich, D. H.; Lubach, J. W.; Offerdahl, T. J.; Lewis, D. H.; Heinrich, J. P.; Munson, E. J.

“Multiple-sample probe for solid-state NMR studies of pharmaceuticals” Solid State Nucl. Magn. Reson. 2006, 29 (1–3), 204–13.

Benjamin N. Nelson, Allison G. Caster, Mary T. Berry. “Gas-phase photoionization of tris(2,2,6,6-tetramethyl-3,5-heptanedionato)europium(III).” Chemical Physics Letters 2004, 396 (4-6), 256-260.

Benjamin N. Nelson. Resonance Enhanced Multiphoton Ionization of Volatile Lanthanide Complexes with Mass Spectrometry Detection. Masters Thesis, 2003.