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Manager Quality

Location:
Northborough, MA
Salary:
150000
Posted:
February 18, 2020

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Resume:

RAJU N. NIVARTHI, Ph.D.

adbubg@r.postjobfree.com

Northborough, MA 01532 315-***-****

SUMMARY:

• Demonstrated leadership in delivering multiple projects and products and successfully assist patient needs

• Multiple groups (QCTS, QC, In-process, and Development) experience in industrial (20 years) and academic research (11 years).

• Extensive experience in protein purification, identification & characterization, assays development and validation, In-process testing, QCTS & QC release methods and, stability testing.

• Expert in macromolecular separation techniques: [HPLC, Capillary Electrophoresis, SDS-PAGE and Two-dimensional electrophoresis; Immunoprecipitation and Western blot; Receptor Internalization and Dimerization; Plasmid preparation and, Transient transfection in HEK cells; Post-translational modifications such as Phosphorylation and ADP-ribosylation; Radio labeling techniques; Radio-immunoassay, Enzyme-linked immunosorbent assay (ELISA), qPCR (including VesiVirus RT- PCR) and GC; Receptor-ligand binding studies; Enzyme assays and kinetics etc].

• Experience in multiple biological products: (Mylotarg, Orencia, Belatacept, Ipilimumab, Cerezyme, Ceredase, Fabrazyme, Myozyme, Thyrogen and, Elaprase life-cycle (discovery to regulatory approval of FDA, EU, Canada, and Brazilian, etc).

• Multiple Instruments installation, operation & performance qualifications, and software validation.

• Experience in technology transfers multiple analytical methods within and outside (CMO) companies.

• Excellent technical, written, verbal and, interpersonal communication skills, ability to work independently, guide and train research associates, and composes reports/presentations and scientific papers.

• Provide analytical data for multiple regulatory filings and post-marketing commitments.

• Prepared and reviewed the analytical portion of license applications. Sanofi Genzyme, Framingham, MA.

Associate Director of Quality Control Technical Services (QCTS) Group. March 2013-Present Senior Scientist/ Manager of Quality Control Technical Services (QCTS) Group. March 2008-March 2013

• Managing more than nine QCTS analysts/scientists and participated in personal recruiting.

• Provide appropriate directions for multiple scientists/Analysts in sample analysis & troubleshooting assays.

• Arrange and attended multiple inter and intra-departmental meetings (such as Interface between the groups, technology transfer, methods, SOP review, projects, and data review) to complete the tasks.

• Providing support for Drug Substance and Drug Product release, stability, and process validation studies using multiple techniques

• For QC laboratory usage, purified/characterized/re-characterized and qualified dozen ELISA reagents, Biacore critical reagents, pNGase, remodeling enzymes, and HIC columns.

• Playing a key role in characterizing and Qualifying multiple in-house ~100 critical reagents and reference materials to support multiple products (Fabrazyme, Cerezyme, Myozyme/Lumizyme, Thyrogen, Elaprase) release. Also coordinated in developing and monitoring critical reagents inventory.

• Documented laboratory deviations, CAPAs, Tasks tracked and closed on-time in Trackwise/Phenix.

• Complete multiple local and global (multi-site) change controls in Trackwise.

• Trended assay controls and individual assay parameters to monitor assay performance, process/product consistency against the specifications

• Completed laboratory move (from 45NYA to 68NYA), equipment purchase (saved 30% cost) and equipment qualifications

• Participated in Quality Technical Agreements (QTA) for Laboratory service

• Provided analytical data for multiple regulatory filings, and post-marketing commitments.

• Participate in internal and external (EMEA, FDA) inspections and Audits

• Participated in FDA Type C meeting briefing package of recombinant remodeling enzymes

• Participated in a regulatory filing to discontinued cleaning ELISA methods and cleaning validations

• Upgrade the pNGase manufacturing (from 10L to 800L) in-house to save $400K per year

• Oversee the product and polyclonal antibody manufacturing and trouble-shooting at CMOS (at Lonza, Patheon, and Covance) Bristol-Myers Squibb Co., Syracuse, NY.

Manager of Immunology and Molecular Biology Group, Biologics Quality Control. January 2005-February 2008 Senior Scientist / Manager, Analytical Biochemistry. April 2001-December 2004

• Managing more than ten scientists in the Quality Control laboratory and developmental Research Laboratory

• Participated and contributed to Strategic planning (Developing RACI Charts, Horizontal Supporting Teams, and establishing Contract labs – such as Bio-reliance, Aptuit, and Covance, etc), Budget justifications (Equipment purchase, Laboratory supplies) and personal recruiting (based on Lab-capacity model).

• Actively participated as a project leader for multiple supporting groups to complete the tasks.

• Monitor the multiple Impurity levels (such as CHO protein, MCP-1, and Protein A, Insulin by ELISAs and CHO DNA by qPCR, etc.) in drug substance and drug product.

• Completed multiple deviations and closed on-time CAPAs

• Experience in Maximo, Pilgrim, LIMS, and Trackwise management systems.

• Provide support for In-process sample and commercial products with SDS-PAGE, IEF, ELISA, Sialic acid, N-linked carbohydrates, and Glycoprotein analysis (Carbohydrates, and Monosaccharides) and Identification/separation by Capillary Electrophoresis.

• Trended multiple assay results and individual assay parameters to monitor assay performance, process/product consistency and setting the proper in-process alert limits and product specifications.

• Arranged and attended multiple inter and intra-departmental meetings (such as Interface, Media raw material management, Immunogenicity, personal recruiting, technology transfer, methods & SOP review, and project & data review)

• Completed multiple products Tech transfer of release methods receiving from the other sites and transferring to the other contract Companies.

• Provided analytical data for multiple regulatory filings, and post-marketing commitments and reviewed BLAs and sBLAs.

• Complete multiple instrumental qualifications and software validation.

• Played key a role in sponsoring Industrial grant ($5k) and saved $200K of company money.

• Participated in preparing multiple Confidentiality and Disclosure Agreements (CDAs), Material Transfer Agreements (MTAs) between the companies.

• Implement multiple new technologies for high-throughput testing - such as ELISA Lab automation (Biomek FX), Biacore 3000, and Biacore C (Surface plasmon resonance-based biosensor technology), and Luminex (Multiplex).

• Participated in FDA, EMEA, Canadian products pre and post-approval Inspections and audits Wyeth-Ayerst Research, Pearl River, NY.

Scientist, Bioorganic/Enzymology. November 2000-March 2001 Scientist, Analytical R&D. November 1999-July 2000

• Performed BACE and Aggrecanase enzyme (which are responsible for Alzheimer's disease) kinetics assays

• Screening the BACE and Aggrecanase enzyme peptide inhibitors from Natural products using microplate spectrofluorometry and HPLC (both UV and fluorescence detectors) methods.

• Manage Four Analysts in cGMP laboratory.

• Coordinate in characterization and quality control of CMA-676, which is the first conjugate of a humanized monoclonal antibody to cytotoxic drug, Calicheamicin, which is marked as Mylotarg for cancer therapy by American Home Products

(AHP).

• Involved in quality documentation, prepared the general technical reports (GTR), laboratory variance reports (LVR), and presenting posters.

Experience with LIMS, Received GMP training and reviewed analyst’s laboratory notebooks

• Purification of polyclonal rabbit anti-calicheamicin antibody, conjugation of calicheamicin-peroxidase conjugates, and validated by ELISA.

• Performed stability, release testing, and clinical compatibility study of CMA-676 to assess the stability of the drug substance and drug product.

• Optimize of Western blot technique for Mylotarg drug product.

• Participated in Pre-approval Inspection (PAI) and played a key role in priority approval of Mylotarg drug.

• Participated in Global filings and Tech transfer of Embrol methods to rest of the world (ROW)

• Improved the efficacy (~15%) of the Mylotarg drug by identifying the conjugation sites New York University Medical Center, New York, NY 10016. October 1993-October 1999 Research Assistant Professor, Anesthesiology Department.

• Managed a research laboratory, including planning and executing multiple research projects.

• Explored the mechanisms that modulate the function of G-protein-coupled receptors (GPCRs), including opioid peptides, non- peptide opiates (Beta2-adrenergic and D2 dopamine receptors).

• Explored the molecular mechanisms of Anesthetics (drugs), and checked the effect of anesthetics on enzymes (such as Protein kinase C, Guanylate cyclase and Tyrosylprotein sulfotransferase); phosphorylated proteins; proto-oncogene products (such as c-fos); cell proliferation markers (Thymidine label Index and protein p53); Nitric oxide-mediated signal transduction.

• Studied to elucidate the mechanism/s and site/s of the interaction of intravenous anesthetics (such as Ketamine, Riluzole, and Pentobarbital) in the NO-guanylate cyclase mediated signal transduction and G-protein involvement.

• The molecular mechanism of cocaine and cocaethylene and alcohol addiction on glial cells study.

• The role of nitric oxide-mediated signal transduction in hypothermia induced by intravenous anesthetics and to delineating the molecular targets of general anesthetic action.

• Develope an improved high-performance liquid chromatographic (HPLC) method for the determination of Tris(hydroxymethyl) aminomethane (THAM), (which plays an important role in maintaining the acid-base balance of the body during liver transplantation) in human plasma, erythrocytes, and whole blood. University of Hyderabad, India April 1987-September 1993 Doctoral Fellow, School of Life Sciences.

• Maintain four research projects.

• Polyclonal antibodies were developed against the nuclear matrix proteins and used as markers in the clinical diagnosis of malignancy.

• I have co-authored a comprehensive review article on nuclear matrix, a non-histone proteinaceous nucleoskeleton structure implicated in transcription, regulation of gene expression, DNA replication eukaryotes.

• Designed and fabricated an apparatus (Multigel Unit) to use in the second dimension of Two-dimensional gel electrophoresis of proteins.

• I am identifying two novel cerebrospinal fluid proteins in non-specific mental retardation (CSF).

• The neurochemical consequences of ethanol (alcohol) intake, with special reference to the physical disruption of the plasma membrane in the brain, were studied.

EDUCATION:

1987-1993 Ph.D., Life Sciences, University of Hyderabad, Hyderabad, India Thesis Title: "Isolation and characterization of nuclear matrix proteins from brain cell types: Possible utility in cancer cell lines".

1984-1986 Master of Science, Biochemistry, Sri Krishnadevaraya University, Anantapur, India 1981-1984 Bachelor of Science, Biology, Chemistry and Zoology, Sri Venkateswara University, Tirupati, India HONORS & AWARDS:

2011 Received “Spot Award” for successfully hiring multiple temps in QCTS to support multiple projects. 2007 Received “Technical Operations President’s Award” for successful 2007 Celltrion Pre-Approval Inspection. 2007 Received “Spot Award” for Teamwork and support of the Celltrion BDS Release testing tech transfer activities. 2007 Received “I Saved EU Launch of Orencia” for releasing the Orencia (abatacept) in EU after approval. 2006 Received “Triumph DOC Award” for the contributions in Orencia (abatacept) Lonza sBLA approval. 2006 Bristol-Myers Squibb “Impact Spot Plus Award” for Quality APT Perfect 2005 Safety Record, February 1st, 2006. 2005 Bristol-Myers Squibb “Impact Spot Plus Award” for Outstanding Drive & Performance to Deliver BQC Goals on December 13, 2005.

2004 Placed the name on “Wall of Tolerance” by National Campaign for Tolerance. 2003 Bristol-Myers Squibb “Impact Spot Plus Award” for Team Work on December 22, 2003. 2003 Published in the “2003-2004: America’s Registry of Outstanding Professionals.” 2002 BMS “Living the Vision Award” and “Instant Impact Award” 2000 Included in “2000 Outstanding Scientists of the 20th century” by International Biographical Centre, Cambridge, England.

1999 Selected as a Biographee in 5nd - 7th Editions of Who’s Who in Science and Engineering “WHO’S WHO IN SCIENCE AND ENGINEERING” by Marquis Who’s Who, New Jersey, USA 1998 Received “National Institute of Drug and Abuse (National Institute of Health), post-doctoral training fellowship”

1998 Listed my profile in “WHO IS WHO” of American Association for the Advancement of Science (AAAS) 150th Anniversary Edition

1998 “Certificate of Merit” was awarded in the (Worldwide) competition of Pharmacia Biotech & Science Prize for Young Scientists 1997.

1997- Selected as a Biographee in 52nd - 58th Editions of “WHO IS WHO IN AMERICA” by Marquis who’s who, New Jersey, USA

1990 “Senior Research Fellowship” awarded in the (National wide) competition from Council of Scientific and Industrial Research (CSIR), INDIA.

1987 “Junior Research Fellowship” awarded in the (National wide) competition from CSIR, INDIA. 1986 Fifth Place in MS

1984 Second Place in BS.

SELECTED PUBLICATIONS: (Note: My name listed as NIVARTHI, RN or RAJU, NN or NAGARAJU, N)

• Jordan BA, Trapaidze N, Gomes I, NIVARTHI RN, Devi LA. Oligomerization of opioid receptors with beta2 adrenergic receptors: A role in trafficking and MAPK activation. Proc. Natl. Acad. Sci. USA 98: 343-348, 2001.

• RAJU N. NIVARTHI, PhD., Ruth Benedict., Jennifer Q. Liang, PhD., Sam M. George, PhD., and Parimal R. Desai, Ph.D.: Purity Determination Of CMA-676 Admixture Samples By ELISA. First Analytical Science Day symposium, Wyeth-Ayerst Research, April 7, 2000.

• Jennifer Liang, Eugene Vidunas, Tracey Yi, Ruth Benedict, Anita Grochulski, Erinn McKell, RAJU N. NIVARTHI, Sam George and Parimal Desai.: Characterization of Highly Loaded Calicheamicin Conjugates of CMA-676. First Analytical Science Day symposium, Wyeth-Ayerst Research, April 7, 2000.

• Trapaidze N, Cvejic S, NIVARTHI RN, Abood M, Devi LA.: The role of C-tail residue in delta-opioid receptor down- regulation. DNA and cell Biology, 19: 93-101, 2000.

• NIVARTHI, R.N, Turndorf, H., and Bansinath, M.: Intravenous anesthetics inhibit the in vitro phosphorylation of two novel membrane-associated guanylate kinase proteins. Anesthesiology 91:A811, 1999

• NIVARTHI, R.N, Turndorf, H., Banisnath, M.: Alcohol pretreatment enhanced the anti-proliferative effect of Cocaine and Cocaethylene in glial cells. Anesthesiology 89: A146, 1998.

• NIVARTHI, R.N, Grant, G.J., Turndorf, H., and Bansinath, M.: Involvement of G-protein in the intravenous anesthetics- induced inhibition of guanylate cyclase enzyme. Anesthesiology 89: A205, 1998.

• NIVARTHI, R.N, Kanchuger, M., Yarmush, L., Turndorf, H and Bansinath, M.: Improved high-performance liquid chromatographic method for the determination of Tris(hydroxymethyl) aminomethane (THAM) in human plasma, erythrocytes, and whole blood. J. Liq Chromatogr. Relat.Tech, 21: 1701-1715, 1998.

• Bansinath, M., NIVARTHI, R.N, Grant, G.J., and Turndorf, H.: Intravenous anesthetics inhibit cerebellar guanylate cyclase enzyme: Implications on nitric oxide-guanylate cyclase mediated signal transduction in mice. Anesth. Analg. 86: S427, 1998.

• NIVARTHI RN, Grant GJ, Turndorf H, Bansinath M.: Effect of Intrathecally administered local anesthetics on protein phosphorylation in the spinal cord. Biochemical Pharmacology 53: 979-986, 1997.

• Bansinath M, NIVARTHI RN, Turndorf H.: Role of nitric oxide-mediated signal transduction in hypothermia induced by intravenous anesthetics. Ann. NY. Acad. Sci. 813: 818-826, 1997.

• NIVARTHI RN, Grant GJ, Turndorf H, Bansinath M.: Spinal anesthesia by local anesthetics stimulates the enzyme protein kinase C and induces the expression of an immediate early oncogene, c-Fos. Anesth. Analg. 83: 542-547, 1996.

• RAJU, N.N, Grant, G.J., Turndorf, H. and Bansinath, M.: Spinal anesthesia increases protein kinase C activity in the spinal cord. Anesthesiology 83: A670, 1995.

• Bansinath, M., NIVARTHI, R.N and Turndorf, H.: Cocaine and Cocaethylene induced inhibition of macromolecular synthesis in glial cells is augmented by alcohol pretreatment. Neuroscience meeting (December 2-3), 1995.

• Vemuri MC, RAJU NN, Malhotra SK.: Recent Advances in Nuclear Matrix Function. A Review. Cytobios 76: 117-128, 1993.

• Vemuri, M. C., RAJU, N. N., Raghunathan, A. and Babu, P. P.: Multiple gels in 2DE - better resolution. In: 2-D Page '91

(Ed.) Dunn, M.J. NHL Institute, London (UK) pp. 29-33, 1991.

• RAJU NN, Sujatha M, Reddy PP, Vemuri MC.: Identification of two novel cerebrospinal fluid proteins in non-specific mental retardation. Neurochemical Res. 16: 23-27, 1991.

• Babu PP, NAGARAJU N, Vemuri MC.: Differences in the plasma membrane proteins of chronic alcoholic rat brain. Membrane Biochemistry. 9: 227-237, 1990.

VISA STATUS: U.S Citizen

REFERENCES: Available upon request please



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