John Fulmer ************@*****.*** 610-***-****
Summary
Accomplished, enthusiastic pharma/biotech professional with scientific, manager and director experience. Successful track record in pharma/biotech, long technical history in process and analytical systems.
Corporate Experience
Janssen/J&J Springhouse, PA 2022-2024
Pharmaceutical Development Project Manager (PDPM)
·Provides end-to-end project support for preclinical through late clinical programs CMC & NCS
Lectrolyst Experimental Station, DE 2021-2022]
Senior Process Chemist
·Provided organic chemistry input to guide making organic compounds through electrolysis
STA Pharma/WuXi Home-based / San Diego, CA / Shanghai, China 2018-19
Director, Business Development – East
·Business+tech support & new sales for pharma/biotech in mid-Atlantic, SE and Midwest, including evaluations of analytical R&D and validation proposals
·Suggest operational CDMO services (e.g. CMC for genotoxic imps) for NCEs in drug substances and drug products (small molecule, peptide & oligonucleotides) totaling ~7 million dollars
Varsal LLC Warminster, PA 2018
Regional Business Manager
·Promoted and acquired new business for small molecule intermediates and amino acids
·Matched specifications of clients with custom products and packaging
·Maintained/expanded existing business for reagents/intermediates, including analytical methods
Neuland Laboratories Ltd Princeton, NJ 2016-17
Associate Director, Custom Manufacturing Services, North America
·Promoted and acquired new business for SM & peptide API synthesis and analytical methods
·Contributed to reduce cycle time of RfP technical evaluations from 4-6 weeks to 2-3 weeks
Avomeen Analytical Services Ann Arbor, MI 2015
Director Business Development, East Coast
·Promoted and acquired new business for analytical, formulation and product services
·Developed extractable/leachable business, evaluating scientific proposals for containers
SST Corporation Clifton, NJ 2013-14
Account Manager, Custom Synthesis / CRAMS
·Responsible for suggesting API, formulations and analytical for clinical/commercial supply of pre-NDA and early post-NDA APIs (chemical & biological) and fine chemical intermediates for 3rd party
Expanded Italian supplier’s new large molecule CRO division through successful project execution
Sanofi Bridgewater, NJ & Swiftwater, PA 2007-13
Manager, North American Sales APIs, Custom Synthesis
·Sales of clinical/commercial supply of pre-NDA and early post-NDA APIs (chemical and biological)
·Assisted with POs and MSAs + analytical totaling $50-60 M over tenure, clinical to commercial scales
Manager, Analytical US, Method Improvement and Validation
·Developed/improved analytical methods from R&D to validation, creation/writing of protocols, executing SWIs and various reports under cGMP, key CMC contributor for analytical methods
·Instrumentation used: GC, HPLC, AA, ICP/MS, UV-Vis, TOC, wet chemical methods
·Biological assays: ELISA, Western Blot, protein analyses
·Six Sigma Green belt, with cross-training in QC ASQ and bacterial fermentation
Lonza Conshohocken, PA 2005-07
Process Chemist IV
·Organic synthesis optimization in lab, kilo lab, pilot and manufacturing scale processes including validation of Phase II through commercial cGMP APIs, IND and NDA CMC writing
·Project planning leader; extensive interactions with production, QC, R&D and QA teams
·Led operation of an RC1 unit / process lab HPLCs and GCs, OQ/PQ and general maintenance
·Responsible for tracking controlled substances in process lab
·Saved a big pharma customer millions of dollars by optimizing each batch campaign by $300K
Rhodia Pharma Solutions Deepwater, NJ 2005
Process Scientist
·Org syn and design/scale-up for bench, kg lab, pilot processes and validation of Phase I-III cGMP APIs + IMs, including analytical experience (HPLC, GC, IR, UV-Vis, DSC, NMR, TLC)
·IND and NDA CMC writing + auditing experience (batch records, SWIs, SOPs)
Sanofi-Synthelabo Malvern, PA 2004-05
Analytical Scientist (contractor)
·Analytical R&D for APIs/excipients and formulations, using various instrumental (HPLC, UV, IR, KF, dissolutions, GC, LC/MS, GC/MS, DSC, TGA) and wet chemistry techniques
·Identified and traced where a key API impurity was generated in a formulation study
Novasep Boothwyn, PA 2004
Research Chromatographer (contractor)
·Assisted in feasibility of scale-up chromatographic method for a project separating chiral APIs
Chirex/Rhodia Pharma Solutions Malvern, PA 2000-04
Process Scientist
·See job description above in 2005
Coelacanth Corporation (bought by Lexicon) New Brunswick, NJ 1999-2000
Building Block Chemist
·Design and synthesis of intermediates for further assembly in novel chemical libraries
·Leadership role in technical advisement kilo-lab scale-up processes, transferring to pilot scale
Johnson Matthey Pharma West Deptford, NJ 1996-99
Development Chemist II
·Chemical Process R&D of APIs and intermediates in cGMP lab, cGMP pilot and cGMP plant scales,
·cGMP/DEA lab scale/validation of APIs; coordinated controlled substances usage in R&D labs
·Hands-on experience using/maintaining FT-NMR, HPLC, TLC, FT-IR, UV-Vis
Academic Experience
Rowan College (RC) & Rowan University (RU) Mount Laurel and Glassboro, NJ, 2019-present
Adjunct Professor, Chemistry
·General Chemistry labs I & II + Organic Chemistry labs I & II
·General Chemistry lectures I & II + Organic Chemistry lectures I & II
Mercer County Community College West Windsor, NJ 2020-present
Adjunct Professor, Chemistry
·Spr 2020 & Spr 2021: lab instructor for 1 gen chem lab; Sum 2021: Gen Chem 1 & 2 lab & lecture
·Fall 2021: Gen Chem I lab and lecture; Spr 2022: Gen Chem II lecture
Rowan College Mount Laurel, NJ 2018-present
Adjunct Professor – Organic Chemistry
·Summer 2018 – ran 2 organic lab sections (one semester 1, one semester 2)
·Fall 2018 – ran 1 general chemistry lab section
Education
Bucknell University Lewisburg, PA
M.S, Chemistry (Organic Chem concentration):
LaSalle University Philadelphia, PA
B.A. Chemistry (Certified by the American Chemical Society)
Rowan College Mount Laurel, NJ
Bio courses taken 2020-2023