Pharmaceutical and Medical Device Expert

Pharmaceutical and Medical Device Consultant (886)

1992 - Present Independent Consultant

1999 Senior Consultant, Stelex Inc., Bensalem, PA

Provider of Software Validation and Development services to pharmaceutical companies like Merck, Warner-Lambert, and J&J.

1998 Management Consultant, Universal Health Watch, Inc., Columbia, MD

Immunodiagnostic company that developed a Rapid Blood Test for HIV.
Organized pivotal clinical trials at Allegheny University Hospital, submitted in a PMA to FDA.

1994 - 1998 Officer of Quality Assurance & Regulatory Affairs, American Red Cross, Philadelphia National Testing Laboratory,

The largest ARC Blood Testing Lab - test samples from five states (DC, MD, NY, NJ, PA).
Reported to National Headquarters QA in Washington.
Implemented a cGMP program for Finished Pharmaceuticals and Reviewed, approved and audited all NTL regulated operations.
Principal coordinator and host for all annual inspections by FDA.

1993 - 1994 Director of Quality Assurance & Control, Bio Transplant, Inc., Charlestown Navy Yard, MA

Developer of biological drugs to increase the utility of organ transplantation. ~Implemented GMP and GLP compliance programs associated with all externally contracted manufacturing and clinical trial operations, conducted mostly in Europe.

1991 - 1993 Director of Quality Assurance & Control, Hybridon, Inc., Worcester, MA

Developed GMP compliance program for pilot scale manufacture of bulk antisense oligonucleotide drugs, to combat viral diseases such as AIDS, Influenza, Herpes, and Cancer.
Established a QC testing lab; approved drug batches for animal tests and for clinical trials.
Instrumental in composition and filing of IND file.

1989 - 1991 Director of Quality Assurance and Regulatory Affairs, Savyon Diagnostics Ltd., Ashdod, Israel

A developer of ELISA-based Immunodiagnostic tests for serological detection of sexually transmitted viral diseases.
Established new QA and QC and redesigned the operations of production, product packaging and materials warehouse, to comply with FDA cGMP for In-Vtiro Diagnostics.
Obtained FDA approval for 510-K files.

1986 - 1989 Manager of Quality Assurance & Deputy Director of Quality Control, BioTechnology General Ltd., Rehovot, Israel

Leading USA-Israeli biotechnology company that develops, manufactures, and markets globally recombinant protein based drugs.
Designed and reorganized operations activities, in Manufacturing, Quality and Logistics divisions, to comply with FDA cGMP regulations for finished biopharmaceuticals.
Instrumental in the transition of operations to a Pilot Plant.

1979 - 1980 Manager of Quality Control Laboratory
Travenol Laboratories, Ltd., Ashdod, Israel

Provider of ALL clinical supply of LVPs for all Israeli hospitals and for the Israeli Army.
Manager the QC laboratory with a staff of 15 chemists and microbiologists, in a manufacturing plant of leading international pharmaceutical corporation.
Approved for sale batches of large volume parenterals.