R A J U N I V A R T H I, P H D

* ****** *****, ************, ** 01532 / 3 1 5 - 3 7 2 - 9 5 1 8 / r n i v a r t h i @ y a h o o . c o m h t t p s : / / www.l i n k e d i n . c om/i n / r a j u n i v a r t h i / Global Quality Assurance leader and Scientific Professional with demonstrated leadership and hands-on expertise delivering multiple projects and supporting antibodies, vaccines, oncology, molecular biology, and biotechnology development for major cGMP clients including Spectrum Pharmaceuticals, Ipsen, ZioPharm, Genzyme, Bristol- Myers Squibb, and Wyeth. With extensive experience in protein purification, identification and characterization, assay development and validation, in-process testing, Quality release, stability testing, data analysis, and CMO oversight. Supported analytical instrument installation, operation and performance qualifications as well as managed the technology transfers of multiple analytical methods within and outside (CMO) companies. Excellent technical, written, and interpersonal communication skills with the ability to work independently. Drug development in all Phases (I, II, III) including Clinical trials of multiple Therapeutics, such as cancer and anti- cancer drugs, Gaucher disease, Fabry disease, Pompe disease (Myozyme/Lumizyme), Thyrogen, Hunter Syndrome

(Elaprase), Niemann-Pick disease type B (ASM), Oral Transplantation (Nulojix), Rheumatoid Arthritis (Orencia) and Acute Myeloid Leukemia (Mylotarg).

Core Competencies:

Analytical Development

Method Improvement

Tech Transfer

Data Analysis

Documentation Review

Validation

Compliance

Regulatory Filings

Deviations

Change Controls

Audits

Formulation and Stability

KEY ACCOMPLISHMENTS

Reviewed and recommended appropriate corrective action to ensure consistency with the quality control function and the quality management system while supporting strategic planning by timely communicating Quality deliverables, constraints, risks, and options, and collaborating with Technical Development, Program management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.

Represented quality control function and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities, and assisted with quality-related information related to (but not limited to) client assessments, RFPs, contracts, and other documentation.

Played 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.

Completed laboratory move (from 45NYA to 68NYA), equipment purchase (saved 30% cost), equipment qualifications and upgraded the pNGase manufacturing (from 10L to 800L) in-house resulting in $400K saving per year.

Managed more than nine QCTS analysts/scientists and participated in personnel recruiting.

Implemented 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).

Fluorescence-activated cell sorting (FACS) was to the specific cell populations based on phenotypes detected by flow cytometry. Internalization of opioid receptors (mu, delta, and kappa) using FACS analysis (at NYU Medical center, NY).

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PROFESSIONAL EXPERIENCE

Spectrum Pharmaceuticals

Biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted drug products. Associate Director, R&D/QC/QA, Cambridge, MA 7/2021 – Present

Rolontis BLA resubmission and updating annual Stability. Preparing Poziotinib IND and monitoring day today activity.

Plan and coordinate all the analytical R&D and quality control activities.

Reviewing CMO multiple analytical assays (Appearance Particulate Matter, pH, Container Closure Integrity, RP-HPLC, SE-HPLC, IE-HPLC, CE-SDS Reduced, CE-SDS Non-Reduced, Protein Concentration, Specific Bioactivity

(Bioassay), Relative Potency, Endotoxin, Sterility, Polysorbate 80, Deliverable Volume (Weight), Break Loose Force, Glide Force, PNG Activation Force, Tip Cap Removal Force) data.

Closed multiple deviations and investigations at contract manufacturing organizations/testing laboratories.

Generate release and stability specifications for raw materials, drug substances and drug products and review stability study design, monitoring, reporting and data trend-analysis.

Perform clinical material evaluation and COA generation designing, developing, implementing, and enforcing best practices, processes, guidelines, systems, and technology to support and enhance the quality control function and the quality management system.

Responsible for implementing, performing, and overseeing internal quality auditing of QC function (including applicable vendors or subcontractors), customer quality audit response, and other QC related quality management system activities.

Ipsen

Global, mid-sized biopharmaceutical company focused on transformative medicines in oncology, rare disease, and neuroscience. Senior QC/QA – Consultant of DPS Group, Cambridge, MA 2/2021 – 7/2021

Represented Quality Control by participating in and leading cross-functional meetings with AS&T, Quality Assurance, Manufacturing, Validation, Regulatory, and others.

Assisted in the technical review of test methods and procedures for testing and release of nano-liposomal drug products, APIs, and raw materials using HPLC, GC, KF, TOC, and ELSD.

Supported in the review and response to the relevant regulatory agency filings.

Review relevant CMC documents in support of regulatory filings (i.e.: IND, NDA, and ANDA) and ensure compliance and/or determine the impact on Laboratory activities

Created and reviewed SOPs, Lab investigations, and Change controls.

Managed timely completion of CAPA, Action Items, Investigations, and decommissioning activities. ZioPharm Pharmaceutical company (Alaunos Therapeutics) Senior QC/QA, Consultant of DPS Group, Cambridge, MA 7/2020 – 2/2021

Provided technical support to process and product development of novel gene therapy drugs for rGBM, solid tumors, and leukemia.

Reviewed, verified, and approved technical data packages of DS and DP stability time points, process transfer protocols, CMC change controls, and batch production records.

Assessed deviations, investigations, root cause analysis, CAPA, and carried out technical writing, editing, and formatting CMC documents, SOPs, and integrated development plans to support clinical development programs.

Oversaw manufacturing development, technology transfers, analytical development, and cGMP manufacture of novel drug substance (DS) and drug product (DP) processes and CMOS (Lonza, ABL, Bioreliance, WuXi, Eurofins) supporting clinical development programs. R A J U N I V A R T H I, P H D

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Performed SME review and data verification of GMP, GLP, GCP records of QC release: Physical description, Color, Clarity, Visual Assessment, pH, Particulate testing, Osmolality, Extractable volume, Virus Particle Enumeration, Infectivity, Specific activity, HPLC, DNA Restriction mapping, sterility, Endotoxin, and Bioassay/ELISA (mIL-12, hIL-12, and INF expression).

Implemented Reference Standard program for Ad5-RTS-hIL-12, annual requalification, and characterization

(such as SDS-PAGE, IEF, AUC, CsCl gradient Ultracentrifugation, glycan analysis, peptide mapping, and intact analysis).

Sanofi Genzyme

Associate Director, Quality Control Technical Services 3/2013 – 12/2019 Manager/ Senior Scientist 3/2008 – 3/2013

Arranged 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 tasks.

Oversaw the product and polyclonal antibody (in rabbits) manufacturing and troubleshooting at CMOS

(Lonza, Patheon, and Covance).

Documented laboratory deviations, CAPAs, tasks tracked and closed on-time in TrackWise/Phenix.

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

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

Provided direction for multiple scientists/analysts in sample analysis and troubleshooting assays.

Coordinated development and monitoring of critical reagents inventory.

Participated in internal and external (EMEA and FDA) inspections and audits, FDA Type C meeting briefing package of recombinant remodeling enzymes, regulatory filing to discontinued cleaning ELISA methods and cleaning validations, and Quality Technical Agreements (QTA) for laboratory service. Bristol-Myers Squibb

Global pharmaceutical company.

Manager/Sr. Scientist, Syracuse, NY 4/2001 – 2/2008 Immunology and Molecular Biology Group/Analytical Biochemistry

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.

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.

Monitored 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 and gained experience in Maximo, Pilgrim, LIMS, and TrackWise management systems.

Provided support for in-process sample and commercial products with Biacore, Bioassay, SDS-PAGE, IEF, ELISA, Sialic acid, N-linked carbohydrates, and Glycoprotein analysis (Carbohydrates, and Monosaccharides) and identification/separation by Capillary Electrophoresis. R A J U N I V A R T H I, P H D

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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 and laboratory supplies) and personnel recruiting (based on Lab-capacity model).

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

Participated in FDA, EMEA, Canadian products pre- and post-approval inspections and audits. ADDITIONAL EXPERIENCE

Wyeth- Ayerst (Pfizer)

Scientist, Pearl River, NY 1999 – 2001

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

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

Managed Four Analysts in cGMP laboratory.

Coordinated characterization and quality control of CMA-676, which was the first conjugate of a humanized monoclonal antibody to cytotoxic drug, Calicheamicin, which was 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 presented posters.

Obtained experience with LIMS, received GMP training and reviewed analyst laboratory notebooks.

Oversaw 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.

Optimized 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

Research Assistant Professor 1993 – 1999

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

Explored the mechanisms that modulated 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 (in mice) at animal facility of New York University Medical center.

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.

Developed 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. EDUCATION

University of Hyderabad Hyderabad, India

Doctor of Philosophy in Life Sciences 1993

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Sri Krishnadevaraya University Anantapur, India

Master of Science in Biochemistry 1986

Sri Venkateswara University Tirupati, India

Bachelor of Science in Biology, Chemistry and Zoology 1984 CERTIFICATES & TRAINING & HONORS & AWARDS & SELECTED PUBLICATIONS

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.

TECHNICAL SKILLS

• cGMP • ELISA • LIMS

• Veeva • Maximo • TrackWise

• CAPAs • CMOs • SOPs

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.

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• 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

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