Analytical Senior Scientist
The Analytical Senior Scientist will be responsible for the design and development of new analytical testing methodologies and the management of testing to support assigned development programs. The Analytical Senior Scientist makes improvements to existing testing methodologies and processes. Contributes tactically and strategically to the division. The Analytical Senior Scientist coaches and mentors junior Associates.
Ensures development of analytical methods and reports are produced in a timely fashion. Coordinates project activities with other Product Development functional areas. Reviews protocols, results, and reports for testing method development. Ensures smooth transition of new methods to Quality Control testing lab. Perform troubleshooting for routine methods as needed.
- 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.
- Benchmarks equipment and systems.
- Performs other duties and responsibilities as assigned.
- BS. 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.