Office Manager/Executive Assistant

Girish. N. Ranadive`, Ph.D.

* ***** *****

Sparkill, NY 10976

Res: 845-***-****, Cell: 845-***-****, Office: 914-***-****

Email: oybjse@r.postjobfree.com

Profile:

Senior Manager in Siemens Healthcare Diagnostics,Tarrytown, NY. Managing group of scientists as a Head of Assay Validation Group, budgeting for the projects through fiscal year. Work with multi functional teams to meet the score cards for timely product launch. Work with Regulatory department for corporate audits, compliance, FDA PMA & 510K submissions in USA as well as European submissions with IVDD and other worldwide submissions. Compliance with CDRH, CBER & PEI for Infectious Disease assays. Meet with customer support teams to discuss and resolve GEM customer complaints and issues. As a head of Validation service, conduct Clinical trials as internal trial site, meet with Medical Director for submission of clinical trials data. More than $ 500K per year in saving as opposed to the use of external clinical trial site. Use of Product Cycle Management or PACE process to track the project timelines, project schedules and associated tasks. Work with Information Design to give feedback on Customer Product Inserts for US and Ex-US markets.

Several years of R & D experience in Bio-organic, Protein chemistry, conjugation chemistry and assay development. Core team leader on several immuno-assays for Biomarkers. Monitoring project schedules through PACE process Phases 1, 2 and 3. Scheduling and tracking the project timelines. Involved in developing control systems specifications (product specifications) during the assay development based on the stability studies, process validation and clinical trial evaluations. I have developed immunoassays for several products, including the markers for cancer, bone metabolism and Therapeutic Drug Monitoring (TDM) markers. GEM customer complaints and CAPA for regulatory compliance, providing the suppport and the data for FDA and other foreign countries including Japan (MHLW) regulatory filing, supporting the validation of different software versions for our ADVIA Centaur & CP systems. Strong communication skills and ability to integrate and work in the multidisciplinary team as well as work with Executive Leadership Team (ELT).

Professional Experience:

Senior Manager & Head, Immunoassay Validation & Stability Group in R & D, for Siemens Healthcare Diagnostics, (Formerly Bayer Diagnostics), Tarrytown, NY. (May 2000 - Present).

• Head, Immunoassay Validation Group (Since 2008): All the immuno assays validation work with validation lot reagents which are built under GMP conditions in manufacturing is done by this group. There are three sub groups / managers handling this work.

 Assay validation group will conduct the non-clinical performance studies for regulatory submissions including FDA 510K & PMA and Eurpean LRQA submission.

 The second group is the Reagent Stability group, which is responsible for the routine stability work on all the assay components including reagents, calibrators and controls. The group is responsible for all the product shelf life and stability claims as well as data submission to regulatory bodies.

 The third subgroup is Internal Clinical Trials group as one of the trial site. The data generated from the trial site is submitted for regulatory filing.

• May 2000 - 2008: Core team member on several immuno-assays for Biomarkers developed on Bayer automation platforms ADVIA Centaur CP, ADVIA Centaur and ADVIA IMS 800i. The assays include Cardiac markers like Ultra Sensitive Troponin-I, Homocysteine, Intact PTH, Vancomycin, Valproic Acid (Therapeutic Drug monitoring), Centacor Cancer markers (CA125, CA-15-3, CA 19-9), PSA, cPSA, CEA and AFP. Infectious Disesase panels including Hepatitis marker assays on ADVIA Centaur and CP.

Girish. N. Ranadive`, Ph.D

 Project management and budgeting for the group and related research activities through the year.

 Managing the group through mid year reviews, career enhancement and coaching activities. Resolving crisis and personnel issues in the group. Deal with human resources for yearly reviews, increaments and promotions.

 Guidance for the Clinical Trial Sites for running clinical trial protocols for various methods.

 Monitoring and Resolving GEM complaints and CAPA (Corrective and Preventive Actions).

 Resolving the issues with manufacturing in executing the Control Systems for Reagent Manufacture.

 Validation of new version of the Software with addition of new methods in the Menu and improvement to existing software.

 Working with Sales and Marketing for the Customer Feedback for the methods and Platform. Process development plan implementation.

 Supporting and providing data for various Regulatory filing including FDA PMA, 510K, CBER, CDRH and registration in foreign countries (LRQA, PEI, Canada, France,MHLW in Japan).

Group Leader & Assay Development Lead Scientist: Diagnostic Systems Laboratories, Inc. Webster, Texas. Now aquired by Beckman Coulter Diagnositcs (March 1995- April 2000)

• Developed RIA, IRMA (ImmunoRadiometric Assay) for Estrone Sulfate, Intact PTH, PSA, ultrasensitive Estriol, Estradiol, DHEA, Androstenedione, ELISA for PSA, IGF-1 IGF-BP3, and Intact PTH. Developed Intact PTH assay for Abbott AxSYM automation platform with DSL as OEM manufacturer.

• Head for Antibody Development program: I was designing and synthesizing various immunogens (Steroids and Peptides), carrying out various immunization protocols with varying amounts of antigen and adjuvants, primary and Booster shots, screening the bleeds for the titers and selecting the appropriate antibodies. Similar immunogens were also used for development of monoclonal antibodies.

• Head for Conjugation Chemistry lab for the design and synthesis of various Small molecule as well as large Peptides, tracers for detection methods. Most of the assays developed were in RIA as well as non-isotopic ELISA format.

Assistant Prof., Dept. of Radiology, Northwestern University, Evanston, IL. July 1992 - Sept. 1994: Research Instructor in the Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, PA. Sept. 1989 - July 1992.

• Cancer Research: Developed a new rapid Tc-99m labeling method for monoclonal antibodies without affecting the antigen binding site. Developed a rapid purification method for Tc-99m labeled antibodies from unbound label. Site specific modification of antibodies through Fc region for targeted Boron Neutron Capture Therapy.

Girish. N. Ranadive`, Ph.D

Education:

• M.S. in Organic Chemistry, 1979, University of Bombay, India.

• Ph.D. in Bio-Organic Chemistry, 1985, Indian Institute of Technology, Bombay, India.

• Thesis: "Role of cholesterol in Cell Membrane Probed via Sterol Analogs."

• Post- Doctoral Fellow, Dept. of Bioscience & Bioengg. Drexel University, Philadelphia, PA. June 1986 - Aug. 1987.

• Post-Doctoral Fellow, Department of Chemistry, University of Delaware, Newark, DE. Sept. 1987 - Aug. 1989.

Patents & Publications:

Patent:

1 Ranadive G. N., Rosenzweig H.S., Epperly M. W. and Bloomer W.D.: U.S. Patent No. 5,208,008: Regioselective Chemical Modification Of Monoclonal antibodies. Issued May 4, 1993.

Publications:

1. Ranadive G. N., Anjaneyulu P. S. R. and Lala A. K.: Carbon-13 NMR of squalene oxide. Relaxation time (T1) measurements. “Indian J. Chemistry”, 1981, 20, 910-911.

2. Nanda Kumari S., Ranadive G. N. and Lala A. K.: Growth of a yeast mutant on ring A modified cholesterol derivatives. “Biochim. Biophys. Acta” 1982 , 692, 441-446.

3. Ranadive G. N. and Lala A. K.: Sterol-phospholipid interaction in model membrane Role of C5-C6 double bond in cholesterol. “Biochemistry”, 1987, 26, 2426-2431.

4. Jain M. K., Yu Bao-Zhu, Rogers J., Ranadive G. N., Berg O.: Interfacial catalysis by Phospholipase A2, Dissociation constants for calcium, substrate, Products, & competitive inhibitors. “Biochemistry”, 1991, 30, 7306-7317.

5. Jain M. K., Ranadive G. N., Yu Bao-Zhu and Verheij H. M.: Interfacial catalysis by Phospholipase A2: Monomeric enzyme is fully catalytically active at the bilayer interface. “Biochemistry”, 1991, 30, 7330-7340.

6. Ranadive G. N., Rosezweig H. S., Epperly M. W., Bloomer W. D.: A technique to prepare Boronated B72.3 monoclonal antibody for Boron Neutron Capture Therapy. “Nuclear Medicine and Biology”, 1993, 20, 1-6.

7. Ranadive G. N., Rosenzweig H. S., Epperly M. W., Sesky T. and Bloomer W. D.: A new method of Technetium-99m labeling of monoclonal antibodies through sugar residues. A study with TAG-72 specific CC-49 antibody. “Nuclear Medicine and Biology”, 1993, 20, 719-726.

8. Rosenzweig H. S., Ranadive G. N., Sesky T., Epperly M. W. and Bloomer W.D.: A novel method for non-chromatographic purification of technetium-99m labeled antibody, A study with B72.3 monoclonal antibody. “Nuclear Medicine and Biology”, 1994, 21,171-178.

Girish. N. Ranadive`, Ph.D

9. Ranadive G. N. and Bloomer W. D.: Solid phase labeling of monoclonal antibodies with Tc-99m using two bifunctional photocleavable reagents. “Nuclear Medicine and Biology”, 1995, 22, 607-612.

10 Ranadive G. N., Mistry J., et al: A rapid and convenient Radioimmunoassay for Estrone Sulfate. “Clinical Chemistry”, 1998, 244-249.

11 Bao-Zhu Yu, Ranadive G. N., Jain, M. K., et al: Gossypol modification of Ala-1 of secreted Phospholipse A2 A Probe for the kinetic effects of sulfate glycoconjugates., “Biochemistry”, 36, 1997, 124**-*****.

Abstracts:

1. Ranadive G. N., Rosenzweig H. S., Epperly M. W. and Bloomer W. D.: Preferential iodination of the Fc region of the monoclonal antibody B72.3. “Antibody Immunoconjugates and Radiopharmaceuticals”,1991, 4, 46.

2. Rosenzweig H. S., Ranadive G. N., Epperly M. W. and Bloomer W. D.: Effects of Fab iodination on the immunoreactivity of a monoclonal antibody. “Antibody Immunoconjugates and Radiopharmaceuticals”,1991, 4, 46.

3. Ranadive G. N., Rosenzweig H. S., Epperly M. W. and Bloomer W. D.: Regioselective Fc chemical modification of B72.3 monoclonal antibody via pH control. “J. Nuclear Med.” 1991, 32, 985.

4. Rosenzweig H. S., Ranadive G. N., Epperly M. W. and Bloomer W. D.: Preservation of the immunoreactivity of a monoclonal antibody by selective iodination of the Fc fragment. “J. Nuclear Med.” 1991, 32,1100.

5. Ranadive G. N., Rosenzweig H. S., Epperly M. W. and Bloomer W. D.: Boronated B72.3 monoclonal antibody for the potential Boron Neutron Capture Therapy. Presented in the Symposium Biomolecular recognition and targeting strategies. “J. Immunotherapy”, 1992, 11, 139-140.

6. Rosenzweig H. S., Ranadive G. N., Mainwaring A. M. and Bloomer W.D.: Modification of Hu-TNF- activity via reaction with hydrazine sulfate. “J. Immunotherapy”, 1992, 11, 140.

7. Ranadive G. N., Rosenzweig H. S., Epperly M. W. and Bloomer W. D.: A new method of Technetium-99m labeling of monoclonal antibodies through sugar residues. A study with TAG-72 specific CC-49 antibody. Presented at The Fourth International Conference on Radioimmunodetection and Radioimmunotherapy of Cancer, Princeton, NJ, Sept., 1992.

8. Rosenzweig H. S., Ranadive G. N., Epperly M. W. and Bloomer W. D.: A solid phase cleaning resin for the non-chromatographic purification of Technetium-99m and Rhenium-186 labeled monoclonal antibodies and their fragments. Presented at The Fourth International Conference on Radioimmunodetection and Radioimmunotherapy of Cancer, Princeton, NJ, Sept.1992.

9. Ranadive G. N., Savjani G. S., Gimpel T., Castracane V. D., Mistry J. S.: A rapid and convenient radioimmunoassay for estrone sulfate. Presented at American Asso. for Clin. Chemists. July 1997.

10. Khaja N., Ranadive G. N., Savjani G. S., Mistry J. S.: An ultrasensitive EIA for measurement of unconjugated estriol in serum. Presented at American Asso. for Clin. Chemists. July 1997.

11. Khosravi M.J., J. Mistry, Ranadive G. N.: Immunoassay of uncomplexed Acid Labile Subunit (ALS) of human insulin like growth factor binding protein (IGFBP) complex. Submitted to Endocrine Society meeting 1999.

12. Ranadive G. N., Bin Fu., Che-An Ku.: Development of second generation high sensitivity Troponin-I assay on ADVIA IMS 800i Immunoassay platform.Presented at AACC (American Asso. for Clin. Chemists). July 2005.

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