Analytical Senior Scientist


York, PA



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.

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