Lead Senior AR&D Scientist / DEA Coordinator Resume Example Novitium Pharma LLC

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…

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

Lead Senior AR&D Scientist / DEA Coordinator Resume Example

Resume Score: 80%

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