Medical Customer Service
Resume:
TATIANA A. NASTASHENKO, Ph.D.
* ********* *******, ********, ** 07866
*********@*****.***
Profile:
Over 20 years of broad hands-on experience working in GLP and GMP regulated environment in Biotech and Pharmaceutical business from R&D, PD and pre-clinical studies to bringing new products to the market, QC/QA/Compliance and product release (including vaccines, pharmaceuticals, diagnostics). Hands-on experience in Incident Investigation, RCA, CAPA, Change Control, SAP, LIMS, TrackWise, CCx.
Quality and Compliance and Result oriented scientist and manager with strong analytical skills, bio-medical background and business sense, professional demeanor and work ethic, communications and customer service skills. Independent thinker, creative multitask and goal-oriented expert in method development, data analysis, presentation and problem solving. Multicultural, comfortable working in fast paced US/global pharmaceutical environment. I am always interested in new projects.
EMPLOYMENT HISTORY
2014 - Novartis, US CPO QA - Batch Release.
Compliance Documentation Specialist.
Responsible for review of Batch documents for compliance with cGMP, license and all regulatory requirements and specifications.
2010 – current: Independent consultant, SME providing services for BioPharma Industry for various process and analytical development applications. Work with Quality management to address issues and identify trends to ensure compliance, facilitate implementation of process improvement within the organization. SME in GMP data reliability audit related to batch records for variety of biological and pharmaceutical products, gap analysis, review and feasibility evaluation of new technologies and proposals. Consulting project with Parexel was focused on GMP data reliability audit for physical & chemical stability, particle size, purity/identity, and residual moisture assays for solid dose products and batch review for the client, as well as review of SOPs, stability documents, testing procedures, preparing reports on findings. Consulting projects for ABC Novacell Inc., IPVE, PATH and MicroPlus LLC were focused on evaluation of new bio technologies and feasibility of their transfer to US, Quality Risk Assessments, audit of suppliers and establishing Quality Assurance Agreements (QAA).
2000-2006 Sanofi Pasteur Swiftwater, PA
Quality Control Deputy Director /Principal Scientist
Managed broad responsibilities from leading QC Department to a scientific support in test and product related issues.
As QC manager, lead the department that consisted of 6 laboratories, performing biological testing and technical release of viral and bacterial vaccines with focus on the product and service quality and compliance.
Prepared budgets, hired employees, directed resource allocation. Reviewed test results to insure required release and stability testing of bacterial and viral vaccines and intermediate products was performed timely to support Production, Product Development, R&D, and Medical Affairs in compliance with cGMP and regulatory requirements. Revised Batch Release documents to ensure required appropriate tests are included in Master Specifications.
Managed Failure Investigation and Change Control. Conducted Incident Investigations, Root-Cause Analyses on OOS results, developed and implemented CAPA, addressed 483 observations. Successfully supported GMP audits and inspections. Performed gap analysis and revision of QC testing procedures. Conducted validation of laboratory test methods. Reviewed and approved all documents pertaining to test methods, validation and qualification (SOP, SWI, Validation Protocols and Reports, etc.). Lead transfer and validation of bio- and analytical methods into the QC laboratories.
Participated in renovating of existing and building new QC laboratories for improved compliance. Lead validation of laboratory facilities and instruments.
As a principal scientist, actively participated in global multi-functional project teams working on product, process and analytical tests improvements, development, transfer and validation of release test methods for licensed and new products (Pandemic Flu, Fluzone, Yellow Fever, Tripedia, Menactra, etc.).
1997-2000 Wyeth-Lederle Vaccines and Pediatrics
Senior Research Scientist, Department of Viral Vaccine Development
Conducted experiments on process development, optimization and scale-up of cell cultures and virus infection (PIV, RSV, Flu, HSV, Rotavirus) on micro carriers.
Developed system of infection of Bovine Rotavirus reassortants in serum-free Vero cell culture in bioreactor that yielded up to 109 PFU/ml, which would allow transfer to large scale operations.
Optimized cell-based bioassays for the testing of new viral vaccine candidates (PIV, RSV, HSV, BRV), prepared SOP's and facilitated transfer of the assays to QC.
Participated in manufacture of GMP supplies for clinical trials and provided documentation on the processing.
Participated in IND preparation for Bovine Rotavirus Vaccine.
1995-1997 Antex Biologics, Inc., Gaithersburg, MD
Staff Fellow, Department of Enteric Vaccines Development
Performed pre-clinical GLP studies for biological evaluation of oral mucosal vaccines against H.pylori, Campylobacter and Shigella: immunogenicity, antigenicity, potency, protection, toxicity, and safety. Set all the necessary laboratory test methods (ELISA for antigens and antibodies, Western Blot, etc.).
Participated in IND preparation for H.pylori and Campylobacter vaccines.
Participated in planning of clinical trial for these vaccines, testing clinical samples and results evaluation.
1994-1995 NIH, NIAID, LID Bethesda, MD
Special Volunteer
In collaboration with IPVE conducted research on Hepatitis E, and experiments to adapt hepatitis E virus to produce infection in cell culture aiming development of vaccine.
1978-1995 Institute of Poliomyelitis and Viral Encephalitis (IPVE)
Russian Academy of Medical Sciences (RAMS), Moscow, Russia. Department of Viral Hepatitis, Laboratory of Biotechnology.
Positions held: from pre-doctoral trainee to scientist, senior scientist and manager, project leader.
As a physician-biochemist, went through rigorous pre-doctoral, PhD and post-doctoral training in Medical Virology at the IPVE. Participated in all departmental projects from research and discovery to the HAV vaccine approval and transfer to manufacturing site, including epidemiological studies of Hepatitis A and Hepatitis E outbreaks, pathogen isolation and virus characterization, cell culture, assay and vaccine development, preclinical characterization of vaccine candidates and Phase I and Phase II clinical studies.
Characterized morphogenesis of Hepatitis A Virus (HAV) non-CPE vaccine candidate strain in tissue culture. Demonstrated, that HAV antigenic determinants are predominantly conformational.
Demonstrated immunogenicity and protective activity of sub-virus particles as well as mature virions in animals (pre-clinical study on marmosets), which was critically important for selection of strategy for vaccine development.
Developed immunoassays for detection of HAV purified proteins, peptides and recombinant proteins.
Results of these experiments were presented in Ph.D. dissertation and used as practical recommendations for industrial vaccine production and choosing strategy of vaccination.
Participated in new vaccine pre-clinical safety evaluation and Phase I clinical studies.
Performed serology studies to support epidemiological investigation of hepatitis A and E outbreaks in Europe and Asia.
Prepared laboratory manual "ELISA for Hepatitis A” (1979) and conducted training classes on immunoassays for epidemiologists.
Lead multi-functional team for production of commercial test-kits for hepatitis antigen and antibody detection in collaboration with PREPARAT LLC.
Project leader and Scientific Counsel for collaboration with the MicroPlus, Inc. In collaboration with scientists from different Institutes of Russian Academy of Medical Sciences I participated in starting biotech companies SALTAN and Micro-Plus (Russia, Moscow) for discovery and commercial production of small and large bioactive molecules that modulate producing activity of mammalian cell cultures, for use in commercial and research applications and led projects for evaluation of their anti-viral activity.
One of the products - "Phosphoprenyl" - showed high efficacy against canine distemper virus and was approved for the veterinary application.
Results of these projects published in scientific journals, presented at the State Committee of Science and Biotechnology, and International Symposia.
Awarded with bronze medal: “For Achievements in Biotechnology” by Russian Ministry of Health and State Committee of Science and Technology.
Hands-on Experience and skills in:
Quality Operations: QA/QC/Compliance. Knowledge of GxP, Regulatory requirements (CBER, EP, ICH, WHO); Incident Investigation, RCA, CAPA, Change Control, Validation, GMP Audit, Risk and Gap analysis.
Serology / Immunoassays: knowledge of the first generation of serology assays (SRID, flocculation, precipitation in agar, complement fixation, agglutination, etc.).
Developed, validated and performed ELISA, RIA, IFA, RIFA, Immunoblot to support vaccine research and development, clinical trials, QC and product release.
Analytical chemistry, biochemistry and organic chemistry methods.
Cell-based bioassays: in-vitro plaque assays (Yellow Fever, PIV, RSV, HSV, Rotaviruses, Baculoviruses, etc cell toxicity assays.
Virology: Virus isolation, adaptation, selection, propagation in cell cultures, infectivity/inactivation/potency assays; characterization and purification of viruses and their antigens. Viruses worked with: Hepatitis A, Hepatitis E, Rotavirus, RSV, PIV, Flu, Polio, Encephalitis, Small Pox, ALV, RAV, etc.
Microbiology: Growth, isolation from a tissue and identification of bacteria; bactericidal assays.
Anti-infectious: Evaluation of compounds for antiviral/antibacterial activity. Selection of biomodulators that affect cell differentiation, growth and specific production.
Cell cultures: Scale-up of tissue cultures on micro carriers in standard and adaptation to animal product free media (FRhK-4, MRC-5, WI-38, AGMK, VERO, HELA, LLC-Mk2, L-929, MDBK, MDCK, MEF, BMS, BT, PT, CHO, OKT-8, primary monkey kidney cell culture).
Vaccine/Product Development: Vaccine strain selection, preclinical and immunochemical characterization of inactivated Pandemic Flu, Fluzone, Hepatitis A vaccines, live attenuated Polio, RSV, PIV, and Rotavirus vaccines, mucosal vaccines against H.pylori, Shigella, and Campylobacter.
Evaluation of immunogenicity and protection of a prototype vaccines based on genetically engineered recombinant proteins and synthetic peptides in animal models (mice, guinea pigs, rabbits, hamsters, rats, monkey).
Manufacture of the cGMP supplies for clinical trials and preparation of the regulatory documentation on the process.
Clinical research: Selection volunteers for clinical trials, review their medical charts and adverse reaction monitoring.
Education
1990 Ph.D. in Medical Virology; Dissertation "Biochemical and Biophysical Characterization of Hepatitis A Virus"; Institute of Poliomyelitis and Viral Encephalitis, Russian Academy of Medical Sciences, Moscow.
1978 M.D (physician-biochemist), graduated from the N.I.Pirogov II Moscow Medical Institute, the Medical-Biological Faculty. 1978 M.S. in Biochemistry, thesis: "Effect of α-Tocopherol-acetate and Na-selenite on DNA-RNA Metabolism of Ischemic Myocardium".
Personality: I am a team player, who always exhibits traits of courtesy, caring, helpfulness and respect for people. Creative, with strong focus on service standards and cost-efficiency, I comply with principles of ethics and integrity, responsibility, confidentiality, protection of organizational assets; adhere to applicable federal and state laws and regulations, policies and procedures. I am fast learner with strong analytical mind and business sense, delivering results on time. Always develop successful network and collaboration with other departments and project teams.
Patents and Publications
Patents
1. Kusov YuYu Nastashenko TA, ...Balayan MS. (1986)
Viral hepatitis A diagnosticum.
Russian Patent No 1302494. 8.12.1986.
2. Kusov YuYu, ...Nastashenko TA, ...Drozdov SG. (1987)
Hepatitis A vaccine.
Russian Patent No 1389059. 15.12.1987.
3. Ovchinnikov YuA, Sverdlov ED Nastashenko TA. (1987)
Recombinant plasmid DNA pUR 291-HAV 22 encoding for hepatitis A virus antigen.
Russian Patent No. 1380209.
4. Ovchinnikov YuA, Sverdlov ED Nastashenko TA... (1987)
Recombinant plasmid DNA pUR 292-HAV 23 encoding for hepatitis A virus antigen.
Russian Patent No.1380211.
5. Ovchinnikov YuA, Sverdlov ED, Tsarev SA, Nastashenko TA. (1988)
Recombinant plasmid DNA encoding for polypeptides for hepatitis A vaccine.
International Patent (PCT) - Invention WO 88/00973.
6. Kusov YuYu, Nastashenko TA, Balayan MS. (1991).
Strain hybrid cultured cells Mus.musculus L.- producent of monoclonal antibodies to recombinant protein of human hepatitis A virus.
Russian Patent No 1611930
7. Sanin AV, Danilov LL, Narovlianskiy AN, Maltzev SD, Nastashenko TA, Prozorovskiy CV (1991). Anti-viral medicine.
Russian Patent No 2005475.
PUBLICATIONS
1. Krasova EI, Nastashenko TA, Onishchenko NA, Seifulla RD, Kuvaev AE. (1979) Effect of alfa-tocoferol acetate and sodium selenite on the change in ATP content and the RNA synthesis rate in the ischemic myocardium. Mol.Farmacology Toxicology 42(3): 251-4.
2. Savinskaya SS, Nastashenko TA, Kazantzeva VA, Andjaparidze AG, Drozdov SG. (1980) Hepatitis A virus in sewage. Hepatitis Sci. Memoranda H2221,1980, 1.
3. Nastashenko TA. The nature of nonspecificity in ELISA for detection of HAV. (1981) in: "Viruses of human and animals".
4. Balayan MS, Nastashenko TA, Aleinik MD... Andjaparidze AG. (1982) Spread of hepatitis A virus in cases of hepatitis A outbreaks in ... WHO Bull.60(2):44-50
5. Andjaparidze AG, Balayan MS, Nastashenko TA. (1983) Combination of radioimmunological and immunoelectron microscopic methods for detecting hepatitis A virus. Vopr.Virusol. 28(4):65-9.
6. Nastashenko TA, Balayan MS, Kusov YuYu... Kazachkov YuA. (1984) Cultivation and properties of hepatitis A virus. In: "Viral hepatitis", Moscow:29-36.
7. Nastashenko TA, Kazachkov YuA, Donetz MA, Andjaparidze AG, Kusov YuYu, Balayan MS. (1985) Isolation and purification of hepatitis A virus ...In:" Actual problems of medical virology", Moscow:215-216.
8. Kusov YuYu, Nastashenko TA, Kazachkov YuA et al. (1985) Localization of HAVspecific antigens in infected cells. Hepatitis Sci. Memoranda H2222, Apr. 1985, 7275.
9. Kusov YuYu, Nastashenko TA, Kazachkov YuA, Fleer GP, Panina LI, Balayan MS. (1986) Association of hepatitis A virus with membranes of infected cells. Voprosy Virusologii 4, 467472.
10. Kusov YuYu, Kazachkov YuA, Grabko VI, Nastashenko TA, Balayan MS. (1987) The use of molecular hybridization method for detecting the RNA of the hepatitis A virus. Dokl. Acad. Nauk SSSR 294(3):731-4.
11. Kusov YuYu, Nastashenko TA, Kazachkov YuA, Panina LI, Nelga IV, Korolev MB, Balayan MS. (1987) Timecourse of hepatitis A virus particles accumulation in the infected FRhK4 cells. Molekul. Genetika 1, 2633.
12. Kusov YuYu, Kazachkov YuA, Nastashenko TA, Grabko VI, Zavodova TI, Nelga IV, Anjaparidze AG, Balayan MS. (1987) Properties of hepatitis A virus particles produced in vitro. Ibid. 3, 1423.
13. Sverdlov ED, Tsarev SA, Markova SV, Vasilenko SK, Chizhikov VE, Petrov NA, Kusov YY, Nastashenko TA, Balayan MS (1987) Cloning and expression of hepatitis A virus genome in E.coli cells. Mol. Gen. (Life Sci. Adv.) N 6, 129-133.
14. Kozhich AT, Ivanov VS, ...Nastashenko TA, (1988) Synthetic peptides from hepatitis A virus capsid proteins and their immunochemical study. J. Cell. Biochem.Suppl.12B
15. Sverdlov ED, Tsarev SA, Markova SV, Vasilenko SK, Chizhikov VE, Petrov NA, Kusov YY, Nastashenko TA, Balayan MS. Cloning and expression of hepatitis A virus genome in E.coli cells. Eighth Intern. Biotech. Symposium. Paris,1988; 99.
16. Kusov YuYu, Kazachkov YuA, Grabko VI, Nastashenko TA, Balayan MS, Sverdlov ED, Tsarev SA, Rokhlina TO.(1988) Detection of hepatitis A virus RNA by molecular hybridization. Voprosy Virusolologii 5, 548554.
17. Kozhich AT, Nastashenko TA Balayan MS (1989) Use of synthetic peptides for investigation of antigenic structure of hepatitis A virus. In: "7-th international symposium on chemistry of peptides and proteins", Moscow :23.
18. Kusov YuYu, Nastashenko TA Balayan MS. (1990) Genome structure and perspectives of recombinant vaccine against hepatitis A . In: "Viral hepatitis", Moscow 22:21.
19. Kusov YuYu, Kazachkov YuA, Dzagurov GK, Nastashenko TA, Balayan MS, Kozhich AT. (1990) Mapping of hepatitis A virus capsid proteins. Voprosy Virusologii 6, 468471.
20. Kusov YuYu, Kazachkov YuA, Dzagurov GK, Nastashenko TA, Kozhich AT, Gabrielyan AE, Chikin LD, Ivanov VT, Balayan MS. (1991) Synthetic peptide 6275 VP3 of hepatitis A virus induces virusbinding antibodies. Voprosy Virusologii 2, 114117 .
21. Kusov YuYu, Nastashenko TA, Kazachkov YuA, Donetz MA, Grishina GK, Berkova NP, Balayan MS. (1991) Antigenic properties of hepatitis A virus particles with different physicochemical properties. Voprosy Virusologii 3, 203206
CV T. A. Nastashenko
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