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PHONE NUMBER AVAILABLEEMAIL AVAILABLEMolecular Biologist/Analyst with extensive training over 20+ years of Pharmaceutical experience and advanced skills in Immunoassays/ Bioassays development and validation for testing and functional characterization. Experience working in a GMP-compliant laboratory; expertise in cell and molecular biology techniques; strong planning, organizational, communication and interpersonal skills. Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment. Strong interpersonal and communications skills. Competent in building relationships, influence, negotiate, and drive organizational engagement. Considerable knowledge in analytical for optimization of processes and products as well as logic skills with a focus on fact-based decision making. Extensive experience in developing and managing program management tools to forecast budgets and resources to accomplish results and meet deadlines and commitments. Excellent supervisory and people management skills for coaching, mentoring, training and development of colleagues.MS Project, PowerPoint, Excel and Word Citrix, Symyx, BIOVIA LIMS e-LogbookPLAJMP SAP environment, PDLIMSPlaniswareCARAJamia Millia University, New Delhi, IndiaMaster of Science (M.S.), May 1989Major: Biological SciencesMinor: ChemistrySpecialization in microbiology and biochemistry (Worked at NII and AIMS New Delhi India)Obtained accreditation as B.S in Biological Sciences in United StatesDelhi University, New Delhi, IndiaBachelor of Science (B.S.), April 1987Major: BiologyMinor: ChemistryREES-Environmental MonitoringTrackWiseSyncade DCA/DOCMANSoftMax ProMicrosoft SharePointInfinityBristol Myers Squibb, New Brunswick, NJ April 2003-PresentSenior Scientist, Biologics Development-Analytical Development and Attribute SciencesAnalytical release and stability testing: Execute biologics assays on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products to support clinical development of therapies, particularly against immuno-oncology (I-O) and oncology diseases By ELISA, Biacore and Potency methodology. Provide training and troubleshooting support to other analysts. Execute analytical method qualification/validation (as applicable) and transfer to QC laboratories. Carefully adhere to approved protocols, as applicable. Working knowledge of cGMP standards used in pharmaceutical and biotechnology industries; performed all assigned cGMP-related activities. Trained analyst for halozyme testing.Regulatory: Experience with CMC regulatory documents, reviewed and provided input for IND filing as needed for potency sections and method validation sections. Managed timeline from method development to regulatory filings. Knowledge of pharmaceutical development, including biologic upstream and downstream processes and analytical methods.Cross functional relation: Maintain culture of collaboration with internal and external stakeholders (QA, HCM, method development, RSCR (Reference Standard and Critical reagent) group,LCS/ IT, Stability Scientist, and Analytical Team Lead) to provide fast and comprehensive turnaround response. Perform duties in full compliance of relevant Good manufacturing Practice (GMP) regulations, Good knowledge of SOP (Standard Operating Procedure) and OSHA (Occupational Safety & Health Administration) corporate policies and site procedures. Author qualification protocols, Standard Operating procedures (SOP), analytical methods and technical reports. Review technical documents, reports and protocols to assure technical merit, accuracy and completeness. Support data trending activities.DCA/ DOCMAN/ LIMS: Familiar with electronic documentation systems (Syncade-DCA/DOCMAN) for routing protocols/reports for review and approval. Laboratory InformationSystems (LIMS) for sample submission, sample assignment, sample review and approval; actively utilize query management tools for sample tracking, reassignment, review, approval within PDLIMS.Low risk Investigator: Qualified Lead Investigator for investigations and quality events (QE) using Track wise and Infinity/ Veeva Vault. Authored deviations, Investigation reports and conducted OOT/OOS investigations related to instruments and Sample tastings. Prepared Change controls for GMP instruments, GMP methods etc. Technical expertise in resolution of deviations, root cause analysis and development of effective CAPA. Reviews and approves documents related to contract laboratory investigation reports (OOT, OOS), change controls, release and critical reagents (RSCR) protocols, reports etc.Audits/ Inspections: Co Lead self-inspection and monthly/ quarterly audits o non f GxP lab areas. Documented and reviewed inspection observations to support inspection readiness of the analytical labs. Conducted and participated department related monthly Safety inspections,. Supported site operations during internal inspections.Diversity/ Inclusion: To promote the growth of positive people culture, led site engagement programs and participated in NJ Engagement Team for team building activities. Active member for B-NOW & POSSIBILITY Lives Ambassador.FACS Aria training -Aug 2007Beckman Coulter Professional Development CenterBiomek FX and NX Pipetting Tools Aug 11, 2009Root Cause Analysis Feb 2021Kinetics and Affinity Analysis Using Biacore Nov 27-28, 2007SUMMARYCOMPUTER SKILLS/ OTHEREDUCATIONPROFESSIONAL CAREER EXPERIENCETRAININGS (In-Class) |
