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Click here or scroll down to respond to this candidateCandidate's Name , MBA, PMPMonmouth Junction, NJ PHONE NUMBER AVAILABLELINKEDIN LINK AVAILABLE EMAIL AVAILABLE Pharmaceutical Professional with R&D, Quality, Compliance, Project Management & Training roles at Pharma & Biotech Solutions-focused leader who collaborates cross-functionally to deliver optimal results. Employ strong work ethic with impeccable integrity in handling sensitive information with discretion. Self-motivated and adaptable with knowledge and working in highly regulated environments. Areas of expertise include: Compliance Quality System - Deviation, Non-Conformance Tracking, Equipment Validation (IOPQ), LIMS, Vendor Management, Assay QC Data Review, Compliance System Trainer, Street Address CFR: Part 210 - 211 & ISO Document Management Tru Vault, Project Management, Technical Writing, Public Speaking, Adobe, Visio, MS Office JANSSEN PHARMACEUTICALS, Raritan, NJ 2019 - 2024GCLP SpecialistServed as GCLP documentalist, Deputy Lab head, trained CAPA champion and quality specialist. Performed business analyst role for LIMS releases by reviewing UAT test scripts. Applied Compliance policies, authoring Validation documents (Equipment IOPQ), Calibration and Maintenance Protocol(CMPs), and departmental SOPs, WIs, FRMs & templates in support of GCLP activities. Performed quarterly LIMS logbook review & Quality monitoring review with QA, annual deviation trending within group, monthly reports for handling alarms. Created deviations in LIMS for process-related errors, drafted Audit responses and incorporated into Trackwise. Led / co-led GCLP and Audit Readiness meetings as well as GCLP core group meetings. Trained laboratory personnel on LIMS and Tru Vault related tasks, performing Acceptable Quality Limit sampling on clinical data for Phase 1, 2 & 3 clinical trials. Conducted GCLP quality data review of ECL, agglutination and MOPA and FACS Admin review, inputting report into LIMS. Hosted and assisted in internal audits and external GCLP accreditation (online during COVID) by reviewing and providing documentation and acting as scribe during audits. Played key role as Tru Vault author, reviewer, and approver of laboratory-associated documents. Trained on Tru-Vault, LIMS, and department-required SOPs through Compliance wire and Summit. COVANCE, West Trenton, NJ 2018Quality Control ReviewerEnsured compliance with cGxP regulations and reviewed laboratory assay data for accuracy. Assisted coworkers with interpretation and understanding of cGCP regulations and other guidance documents, maintaining QC inventory and performing follow-up actions and reducing departmental citations. Maintained working knowledge of client SOPs and requirements, applying to data-review tasks for laboratory assays(MSD / ELISA) and inputting results into LIMS. Trained on company, client and departmental SOPs. KAIZEN TECHNOLOGIES, Edison, NJ 2016 - 2017Project Management Professional (PMP)Completed training course (50 PDUs) funded by Ready to Work grant in New Jersey. Prepared Statement of Work, Business Case, and Project Charter, continuously improving efficiency and reducing costs by creating repository for Corporate Procedural Documents. HEALTH EC, Piscataway NJ 2012 - 2014Training / AnalystCompleted 3-month Business Analyst training including SDLC, requirements gathering, UAT testing, followed by Blue Cross Blue Shield (BCBS) project. Performed loading, validation, and special edits on health care data in Docuwise. Analyzed process mapping of loaded national groups and documented action required via variable tables. Coordinated, organized, and prioritized project associated tactical tasks and business data, easing claims enquiries. Candidate's Name EMAIL AVAILABLE Page TwoVAXINNATE CORPORATION, Cranbury, NJ 2010 - 2011Research Associate III, Quality ControlServed as QC analyst working in cGLP / cGMP environment and performing in-process testing and technical transfer to CMOs. Organized document control and revision of analytical procedures for technical transfer to Subcontractors, performing assays and contributing data towards CMC section for Regulatory filing. Worked with external vendors, ensuring compliance and tracking analytical testing using material change of custody. Contributed to batch record completion and release of buffer samples to QA custody, training on Out-of-Specification(OOS), Non-conformance (NC), Corrective Action Preventive Action (CAPA), Deviations, and Amendments SOPs. Conducted assays and test methods according to 21 CFR and FDA guidelines, including ELISA, BCA (colorimetric assay), LAL endotoxin, SDS-PAGE, and cell culture technique TLR-5 assay (in training). BRISTOL MYERS SQUIBB, Plainsboro, NJ 2004 - 2009Associate Training Manager, PPM Group, Plainsboro, NJ 2008 - 2009 Developed and delivered training presentation and online demonstration of BMS compliance website in seminar and breeze module formats. Enabled changes to the website and incorporated current practices for Sales force operations. Organized and managed cross-functional team to develop departmental SOPs and Work Instructions, maximizing individual compliance with BMS Policies by approval / editing of sales communication and training material via Mercury. Interfaced with external vendors and internal resources, developing Communication materials that enhanced learning, and managing e-submissions / approvals with Legal and Compliance team. Research Scientist, Bio Analytical Sciences, Chemical Enzymology, Pennington, NJ 2004 - 2008 Created and conducted assays to determine efficacy of novel BMS compounds, presented poster at 16th Annual Scientific Symposium, PRI, BMS, served as departmental safety representative, and received BMS PRI star award. Joined Bioanalytical Sciences as contractor and promoted within a year in Chemical Enzymology. Analyzed enzyme inhibition data from cyno experiments, providing critical input to DWG for IND filing and developing protocol to test reversibility of potent enzyme inhibitors and ex-vivo assay, assessing inhibition of enzyme in tissue sample. Performed routine gel filtration, HPLC, and western blot for characterization and purification of enzymes according to 21 CFR and FDA guidelines, performing detailed studies evaluating mode of inhibition (M01) of BMS inhibitors. Efficiently used Graphpad Prism, Kaleidagraph and Grafit. Trained on PD-LIMS and conducted in-process testing for BMS biologicals, using ELISA, picogreen, UV spectroscopy and protein purification methods that included SEC HPLC (Waters and Shimadzu). ELAN PHARMACEUTICALS, Princeton, NJ 1998 - 2003Senior Research Associate, Biological Evaluations / Pre-Clinical Development Developed novel operating procedures for cytotoxicity assays and in-vitro combination studies. Led project management initiative regarding OSHA and document control for QA applications. Delivered research seminars to lab personnel. Coordinated implementation of high-throughput screening technology for drug discovery, developing associated software- based techniques.Education Master of Business Administration (MBA), Rutgers Business School, New Brunswick, NJ Master of Science (MS), Biotechnology, MS University, Monthly scholarship from Department of Biotechnology Bachelor of Science (BS), Microbiology, Top-5% Class Ranking, Delhi University, New Delhi, India Professional Development, Certification, & Affiliations Online GCLP Coursework, Research Quality Association (RQA), 2023 PMP Certificate, Project Management Institute, Good Standing Through 2026 Member, Healthcare Business Womens Association (HBA) Member, Project Management Institute (PMI) Environmental Health and Safety (EHS) Committee Representative Chemical Enzymology Department, Hopewell BMS Compliance Course, Completed with Merit, Occupational and Safety Health Administration (OSHA), Philadelphia, PA; Designated Chemical Hygiene Officer for Elan's Princeton facility. Candidate's Name EMAIL AVAILABLE Page Three Patents and Publications Candidate's Name , Donna Pedicord, Yuval Blat et al. Cofactor specific modulation of 11HSD-1 inhibitor potency, Biochimica Biophysica Acta 1774 PHONE NUMBER AVAILABLE H.Y. Tang, S. Ali, Candidate's Name , A.S. Janoff, and E. Mayhew, "A novel ceramide derivative, TLC-144, induces apoptosis in human tumor cells through the activation of caspase 8/FLICE," submitted as US Patent Application and Presented at the annual meeting of American Association of Cancer Research, San Francisco, CA, Apr 2000 Candidate's Name , "Mechanism of action of ELL-12 (Insight into involvement of caspases)," Research seminar at The Elan Corporation, Jan 2002 "Caspases and Apoptosis," Research seminar Jul 1999 |
