Takeda – Vitamins C Plant Start Up and Commissioning (Wilmington NC, 1990)

Capacity limitations studies in producing Vitamin C. Extensive forensic analytical of spent electrolysis membranes, equipment controls optimization and improved electrolytic cell maintenance lead to a real capacity gain of 15% and an electrical efficiency improvement of 20%, resulting in over $1.2 million annual savings.

Vitamin C – Hoffmann­La Roche (Belivedere NJ 1992)

Distillation optimization studies and control system upgrades savings of $150k per year.

In depth production data analysis of the final Vitamin C (6000 gal) reactor system was performed to improve product recovery. 30% increase product recovery rates.

Vitamin C precursor (NaDAG under O2, NaOH, Pd/C) batch catalytic system optimization. Creative retrofit design for a dual train ‘triple cascade’ continuous reactor train with extensive DCS modifications. Non­linear modeling studies. 30% increase in capacity, 20% energy and material savings. $1.5 million per year.

Acted as lead process control engineer in support for two major plant DCS retrofit projects ($45 million capital scope).

Proctor & Gamble Pharmaceuticals (Norwich NY 1998):

Actonel (ResidronateNa) drug substance polymorph product quality studies to support $200 million revenue stream and launch at new European facility. Lead pilot plant and lab studies using crystallization theory and computational fluid dynamics modeling, to meet drug product registered release specifications.

Peptide Synthesizer. Lead the design and commissioning of a new synthesizer unit ($400k, 20L reactor system) with a novel solvent recycle strategy.

Developed low temperature batch reactor system ($300k, ­60 C) to support sensitive stereo selective reactions.

Imclone/Lilly BioPharmaceuticals (Branchburg NJ, 2004):

Bioprocess manufacturing database datamart and visualization layer development.

La300a: Tech transfer key lead support member for a novel therapeutic antibody for alzhiemers indication. Provided bioreaction engineering design for 11kL bioreactor systems where metabolic (OUR, CER) capacity increases of more than 100% were required.

Erbitux cell culture improvements gained a 20% increase in cell culture titer and production performance.

Technical bio-manufacturing lead for 3 oncological antibody clinical trial candidates.

Samsung Biologics (Incheon Korea, 2013):

Director Manufacturing Technology Team. Introduction of three antibody products into production scale operation: ipilimumab (BMS), rituxan (Roche), and nivolumab (BMS). 

Completed the Plant #1 process validation qualification campaign for ipilimumab (BMS), May 2014.

Teruisi Biologics (Huzhou China, 2015):

VP Manufacturing. Bioprocess Plant design for Monoclonal Antibodies. Plant design, clean room design, plant validation strategy and design. Engineering contract and capital purchase contract management.

Nikon Cell Innovation (Shinsuna, Tokyo Grand Harbor, Japan, 2017):

Project Manager, MODA Environmental Monitoring System Implementation, new Cell and Gene Therapy production facility. Complete Computer System Validation design, validation strategy and qualification.

BioThera Solutions, Ltd., Hedy Corp,(Gaungzhou, China 2018):

Corporate leadership for late stage process development including GLP cell culture and protein purification process development and GLP/cGMP pilot scale pre-clinical supply and process scale-up. PD Department leader over three groups of 25 staff. Designed and commissioned new PD labs (1000 sqm). Late stage process QbD studies for 3 mAb global market biosimilars.

Top Alliance Biopharm, Junshi (Wujiang, Jiangsu, China, 2017):

Building new MST department for Late Stage Process Development and Technology Transfer. Oversight of buildout and commissioning of 2 process characterization labs (supporting DS and DP) focused on QbD/CMC process development functions, and continuing Manufacturing Technology and Sciences oversight for the commercialization of  late stage monoclonal antibody therapeutics JS001 and JS002. Applied statistical and data sciences oversight for bio-process development data systems and tools with SAS/JMP, R, R-Shiny, MySQL and other tools supporting process QbD.