Analytical Senior Scientist

Job Description

Essential Functions:

• Manage project testing support consistent with assigned development program requirements; contribute and represent Analytical R&D while serving on cross-functional teams chartered to develop and commercialize new drug delivery products; interact effectively fulfilling functional responsibilities, collaborating with functional counterparts & customers to assure overall project success.
• Draft R&D stability protocols consistent with the stage of the project.
• Development of new analytical testing methodologies which can be implemented for setting in-process and final product specifications (assay, impurity/related substances, dissolution and residual solvents).
• Author method development protocols/ reports and assist with method validation/ verification/transfer to the Q.C. laboratory, as applicable.
• Develop and troubleshoot stability-indicating methods for drug products.
• Assist with the investigation of analytical testing results failures.
• Design & conduct analytical testing on lab and production scale materials; draw valid conclusions upon analysis of technical data from experimental testing, expertise, and literature references.
• Define test methodologies and requirements for specific analyte of interest; prepare test samples and conduct tests on in-process intermediates and/or finished products as required to support development programs; make improvements to existing testing methodologies as necessary to support development or product improvement projects.
• Participate in the establishment of testing specifications and validation of testing methods thereof.
• Transfer analytical methods to QC chemists.
• Anticipate and proactively address potential lab method development, method validation, clinical, regulatory and commercial testing issues during development.
• Support and contribute to maintaining office and laboratory environment consistent with LEAN 6S and all regulatory requirements.
• Ensure up-to-date compliance with all training requirements; understands overall business strategy and plans while also working to execute responsibilities in accordance thereof.
• Make identifiable and beneficial contributions to continuous improvement; perform all duties safely and consistent with established company and divisional procedures and guidelines; actively comply with and endorse department, divisional and company objectives.
• Responsible for following all relevant regulations (e.g. DEA, FDA, OSHA, EPA, DEP, etc.) and company procedures.

Additional Responsibilities:

• Benchmarks equipment and systems.
• Performs other duties and responsibilities as assigned.

Job Specifications:

• S. in chemistry or related field with a minimum of 10 years pharmaceutical method development experience
• 10+ years experience working with HPLC analytical methods for analysis of transdermal and/or solid oral dosage form experience; proven track record of successful analytical methods development leading to successful method validation
• 7+ years experience in analytical method validation and pre-formulation analytical work in a pharmaceutical environment.
• 7 + years experience in an FDA regulated environment as well as familiarity with 21CFR Part 211 Federal regulations.
• 5+ years experience in analytical group supporting development of ANDAs & NDAs
• Skilled technical writer and experience in writing analytical method development and validation reports
• Organization skills
• Problem-solving and trouble-shooting capability
• Highly experienced in FDA, USP and ICH guidances/ monographs applicable to analytical testing.
• Must communicate fluently in English and have excellent communication and interpersonal skills
• Capable of performing duties independently with limited supervisory direction
• Ability to generate reports and make technical presentations to internal and external audiences
• Ability to manage multiple priorities in order to meet company objectives
• Familiarity and aptitude with a wide variety of chemical analytical techniques and associated data analysis
• Promotes the use of safe work practices to ensure that AR safety standards are met on a daily basis.
• Represents the organization in a professional and positive manner.
• Computer literacy with good working knowledge of statistical tools, statistical process control, Excel, Word, and PowerPoint computer packages.