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Lead Senior AR&D Scientist / DEA Coordinator Resume Example

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LEAD SENIOR AR&D SCIENTIST / DEA COORDINATOR
Professional Summary

Senior Scientist ( 9 years) Results-oriented and resourceful scientist (analyst) with substantial experience in delivering exceptional leadership, guidance, and supervision to junior analyst with keen focus on building relationships. Equipped with outstanding communication/interpersonal skills; capable of building and maintaining relationships with multi-disciplinary network of individuals to drive strategic cohesive functions. Strong scientific acumen, in-depth knowledge of GMP regulations, ICH guidelines, and compendial monographs/methods. Proven leader, with success directing high performing teams to achieve project goals and objectives within budgetary and time constraints.

Skills
  • Research & Development
  • Full Life Cycle Project Management
  • Validation Protocols
  • Chromatography (LC, LC-MS, GC, GC-MS)
  • Quality Assurance/Testing & Control
  • Experimental Design & Analysis
  • Process Scale-up & Transfer
  • Laboratory Data review and Regulatory audit.
  • Team Supervision
  • Regulatory Compliance
  • Training & Leadership
  • Decision-making, Validation
  • Product development, Annual reports
  • Full Life Cycle
  • Leadership
  • Processes
  • Project Management
  • Protocols
Work History
Lead Senior AR&D Scientist / DEA Coordinator, 01/2017 to Current
Novitium Pharma LLC – East Windsor, NJ
  • Formulate validation protocols and develop validation reports as part of ANDA submission, while leading transition of analytical methods in compliance with standard policies/guidelines.
  • Deliver subject matter expertise in analytical methods to develop and commercialize products, while providing proactive support to process analytical technologies for commercial manufacturing processes.
  • Successfully and effectively manage testing with CTOs and CMOs to achieve successful ANDA submissions.
  • Contribute to and/or handle laboratory investigations for events and Out of Specification results.
  • Gather Data and perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, Assessment of event for impact to Safety, Identity, Strength, Quality & Purity (SISQP), Identification of Corrective and Preventative Actions(CAPA's) to reduce deviation recurrence, performance and leading of Risk Assessments.
  • Perform review of day-to-day analytical testing data and Generate Certificate of analysis for CTOs and CMOs.
  • Manage and dispose substance samples and reference standards in safes/cages for laboratory, while strategically positioned as DEA coordinator.
  • Train and mentor other analysts to conduct laboratory procedures and analysis and ensure continuous performance improvement.
  • Prepare drafts of laboratory work, while ensuring compliance with GLP/GMP requirements to optimize operational efficiency.
  • Key Transferable Skill: Optimized project outcomes and deliverables by delivering analytical support to new projects regarding analytical development, validation, and Quality control method transfer work for projects via man.
  • Improved analytical methods and procedures at CMO and CTOs by devising/deploying strategic plans, while serving as one of key element of organization for average 8-9 ANDA submission year.
Analytical Validation Chemist, 01/2015 to 01/2017
Lupin Pharmaceuticals – Somerset, NJ
  • Spearheaded and delivered accurate and complete notebook records by steering analytical method development/validation, while conducting investigational studies in compliance with SOPs and protocols.
  • Streamlined analytical methods for qualification/release testing of products by creating/performing analytical testing methods regarding drug products, drug substances, and excipient.
  • Key Achievements:.
  • Facilitated informed decision-making by preparing/reviewing procedures, protocols, and summary reports for product development initiatives.
  • Established and authenticated method almost 5-6 projects a year, while providing proactive support to company in ANDA submission by resolving FDA deficiencies.
Quality Control Chemist, 01/2014 to 01/2015
Heritage Pharmaceuticals Inc. – East Brunswick, NJ
  • Conducted comprehensive analysis of transfer documentation including technical transfer protocols or reports to achieve designated targets.
  • Analyzed raw materials, reviewed bulk/finished products, and performed detailed analysis of scale-up, process/cleaning validation, and stability samples by leveraging instrumentation such as HPLC, UPLC, GC, UV-Vis, FTIR, dissolution apparatus, and particle size analyzer.
  • Maintained and updated analytical test results and conclusions by preparing technical reports and other documentation.
  • Performed high-level analytical testing by managing and operating specialized scientific equipment.
  • Key Achievements:.
  • Ensured seamless operations by engaging in out-of-specification/failure investigations, identifying/mitigating potential discrepancies, and recommending corrective actions.
  • Enhanced product quality and functionality by coordinating with laboratory technicians, production personnel, and customers.
Research Associate, 01/2012 to 01/2014
Norwich Pharma INC – Norwich, NY
  • Executed analytical method validation for contract labs or vendor as CMO chemist.
  • Coordinated development of analytical and control tests for API, starting materials, process intermediates and drug product.
  • Coordinated requirements and acquisition of analytical documentation/data/reports needed to support, or to be included in, submissions to Investigational New Drug applications (INDs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), amendments, supplements, and annual reports; authors and reviews regulatory documents and responses.
Education
M.S: Pharmaceutical ChemistryNew Jersey Institute of Technology - Newark, NJ
  • Biochemistry
  • Advance Biochemistry
  • Organic chemistry
  • Pharmaceutical Analysis
  • Advanced Pharmaceutical Analysis
  • Environmental Analayisis
  • Project Management
  • Laboratory management …Continued…
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Resume Overview

Companies Worked For:

  • Novitium Pharma LLC
  • Lupin Pharmaceuticals
  • Heritage Pharmaceuticals Inc.
  • Norwich Pharma INC

School Attended

  • New Jersey Institute of Technology

Job Titles Held:

  • Lead Senior AR&D Scientist / DEA Coordinator
  • Analytical Validation Chemist
  • Quality Control Chemist
  • Research Associate

Degrees

  • M.S : Pharmaceutical Chemistry

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