Bharat B. Kikani

Careers Summary

Highly innovative business oriented research scientist with demonstrated track record in immunoassay design, product and process development, protein purification, assay validation, and technology transfer. Played key role in developing 12 products in several new markets.

Professional Experience

POLYPROBE, INC., Philadelphia, PA
Senior Research Scientist

Design and develop protocols for conjugation of oligonucleotides and dendrimers to Alkaline Phosphatase and Streptavidin. Implement these procedures to support research and manufacturing requirements.

• Establish conjugation capability at Polyprobe. Synthesize immunodendrimer molecules.
• Interface with assay development to optimize conjugate selection and kit performance.
• Contribute to oligonucleotide purification and process development.

CENTOCOR, INC., Malvern, PA 1994-1996
Senior Research Scientist, Diagnostics Product Development

Managed research and the transfer to manufacturing of immunoassays for the detection of tumor markers .

• Extensive experience in developing immunoassays, such as optimization of conjugate synthesis and performance, stability and assay correlation with existing methods. Experience 'includes the development of novel approaches to study immunoassay kinetics and detection methods.
• Expertise in immunoassay product development with several assays formats utilizing automated platforms. Experience in protein purification using immunoaffinity, ion exchange and gel filtration chromatography techniques on HPLC, FPLC and BIOCAD instruments. Protein characterization experience includes capillary electrophoresis and electrospray LC/MS.
• Member of several international product/project management teams with various industrial partners to develop assay validation data for submission to several regulatory agencies.
• Developed and implemented several SOPs for transferring product development processes to manufacturing under GNT and ISO 9000.

DNA PLANT TECHNOLOGY/QUANTIX, Cinnaminson, NJ 1990-1994
Senior Research Scientist/Project Leader

Responsible, as project leader, for the development of immunoassay for explosives, PCBs, herbicides and petroleum components. Required close interaction with all levels of staff within and outside the company.

• Contributed significantly to preparing and presenting research proposals resulting in $5MM in product development revenue.
• Managed synthetic chemistry and assay validation groups. Designed and executed synthetic routes for haptens of high purity to serve as immunogens, tracers and analytical reference standards.
• Designed and optimized the conjugation of haptens to carrier molecules for use as immimogens and screening and enzyme conjugates.
• Interfaced with scale up and production. Responsible for trouble shooting and problem solving pertaining to conjugation chemistry.
• Contributed to the validation of immunoassays with EPA methodology for trinitrotoluene, polynuclear aromatic hydrocarbons and chlorothalonil. Prepared draft methods of submission to the EPA.
• Participated in EPA/Industry consortium to develop guidelines for comparing various methods.
• Played key role in developing 10 new immunoassay products for environmental markets. Combined sales: $3MM per year. Helped demonstrate product viability.

Research Scientist 1990-1992

• Established synthetic organic chemistry capability at Quantix.
• Synthesized and characterized haptens through single and multi-step reactions to serve research and manufacturing requirements.
• Prepared and characterized conjugates.

Education:

Graduate Program in Management Penn State University, MEBA expected December 1997	1995-present
Ph.D. Program in Medicinal Chemistry Philadelphia College of Pharmacy and Science	1986-1990
M.S. Medicinal Chemistry Philadelphia College of Pharmacy and Science	1986
B.S. Chemistry University of Bombay, India	1983

Continuing Education:

"Analytical Methods in Protein Chemistry," ACS short course, 1995

"Frontiers in Organic Chemistry," Stanford University - Intensive six day short course, 1994

"Modem Methods in Organic Chemistry," ACS short course, 1993

"Chiral Separations," Philadelphia section of ACS, 1982

Patents, Publications, and Presentations:

• One U.S. and four international patents.
• Four publications including book chapters; several abstracts of papers presented at scientific meetings.