Experience

Omeros Corporation

• United States
• Biotechnology Research
• 100 - 200 Employee

• Manager, Chemical Development

  • Mar 2016 - Present



Arena Pharmaceutials

• San Diego, California

• Scientist

  • Oct 2007 - Jan 2016

  Develop scalable chemical processes and deliver API for Phase I and Phase II clinical testing. Document process technology in written communication suitable for tech transfer to 3rd party contract manufacture (Phase III and commercial scale). Serve as onsite technical expert and Person in Plant (PiP) support during kilo-lab/pilot plant, registration, validation, and initial commercial manufacturing campaigns. Aid in documentation required for NDA submission. Author, edit, review documentation needed for GMP compliance (SOP, Master Batch Records, IQ/OQ/PQ). Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist

  • Aug 1999 - Oct 2007

  • Delivered quantities of API in suitable purities for both early and late stage preclinical (non-cGMP) testing, often under very tight timelines. Quantities ranged from a few grams to several kilograms. Received multiple Special Recognition Awards. • Designed and conducted experiments to evaluate, redesign, and refine synthetic routes of drug candidates and develop scalable processes to deliver API for phase I and phase II clinical testing. • Documented process technology in written communication suitable for transfer to either internal cGMP facility or external 3rd party contract manufacture. • Served as technology support during kilo-lab/pilot plant runs under cGMP. • Functioned as group outsourcing lead: o Researched sources, prepared tech packages and bid requests, negotiated costs, coordinated deliveries with project timelines, and maintained follow-up on any delivery or quality issues. • Served as mentor/coach: o Medicinal chemistry colleagues (BS/MS and PhD) doing rotations in CRD. o Colleagues new to chemical process research and development. o Received Special Recognition Awards. o Several Job Performance Reviews emphasized coaching as a special talent • Serve as CRD safety officer: Show less



Borregaard Synthesis Inc.

• Newburyport, MA

• Sr. Process Develpment Scientist

  • Oct 1997 - Sep 1999

  • Managed Chemical Development projects from early, paper chemistry, stage through development to pilot plant scale and transformation into production scale. o Evaluated proposed chemical processes for scale-up and determined resource needs o Designed, conducted or supervised laboratory experiments, and evaluated results to anticipate and minimize scale up issues. o Planned timelines, material requirements, and cost of manufacture for projects entering pilot plant o Coordinated with QC, Sales and Marketing, Production, and EH&S on projects entering production o Supplied timely updates to upper management as well as customers • Evaluated equipment needs to expand site capabilities. o Researched, designed and supervised retrofit of production (4000 L) reactor with a multi-plate vacuum distillation system. The installation reduced the reprocessing rate for BSI’s main product from 33% to less than 2%, reducing the cost of manufacture, increasing site capacity, and reducing customer complaints. o Researched and evaluated production scale centrifuges and pressure filters. Collaborated with site engineer on installation. Reduced the potential for operator exposure, product cross contamination, and processing time. o Researched, evaluated, negotiated, and procured up to date HPLC and GC equipment for PO&PS group. After training the PO&PS staff, this equipment increased productivity and shortened process development time by not only providing more data but also in real time. • Coached/mentored R&D chemists (PhDs) on experiments and parameter evaluations that would ease chemical procedures through the development process from bench into production. • Authored safety/scale up protocol Show less



Dow

• United States
• Chemical Manufacturing
• 700 & Above Employee

• scientist

  • Jan 1987 - Sep 1997

  Chemical research and development. Mutlistep organic chemistry process research and development from early stage route selection through to production. Biologically active molecules. Chemical research and development. Mutlistep organic chemistry process research and development from early stage route selection through to production. Biologically active molecules.