Lead Senior AR&D Scientist / DEA Coordinator Resume Example Danimer Scientific

LEAD SENIOR AR&D SCIENTIST / DEA COORDINATOR

Professional Summary

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.

Work History

Lead Senior AR&D Scientist / DEA Coordinator, 01/2017 to Current
Danimer Scientific – Gates , NY

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.
Contribute to and/or handle laboratory investigations for events and Out of Specification results.
Gather Data and perform Root Cause Analysis (RCA) to determine most likely cause of 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.
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:.
Improved analytical methods and procedures by devising/deploying strategic plans, while serving as one of key element of organization for average 8-9 ANDA submission year.
Optimized project outcomes and deliverables by delivering analytical support to new projects regarding analytical development, validation, and transfer work for projects.

Analytical Validation Chemist, 01/2015 to 01/2017
Foundation Medicine – Cambridge , MA

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 per 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. – City , STATE

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 – City , STATE

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.
Key Achievements:.
Successfully Provided quality oversight of analytical method validation lifecycle activities for clinical and commercial processes (development of validation strategy, analytical method reviews, compendial method verifications, method performance monitoring (trending, assay remediation, etc.), reference standards & critical reagents.

Education

M.S: Pharmaceutical ChemistryNew Jersey Institute of Technology - City, State

Resume Overview

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

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