Senior Chemist
The Senior Chemist acts as a subject matter expert in critical analytical development areas, providing technical oversight and support for new product development (NPD) projects. They independently manage method development, validation, and contribute to regulatory and continuous improvement activities
Responsibilities
- Lead analytical test method development and validation for dissolution/elution (USP APPII/APPVII), liquid, and gas chromatography.
- Plan and schedule laboratory activities independently to meet project deadlines.
- Author technical reports, validation documents, and provide clear updates to cross-functional and cross-site teams.
- Support laboratory investigations by identifying root causes and implementing corrective actions.
- Drive continuous improvement projects aimed at reducing lead times and achieving cost savings.
- Assist in training new colleagues and support internal and external audit programs.
- Provide technical support for regulatory submissions.
Requirements
- Proven expertise in dissolution/elution testing, liquid and gas chromatography, and analytical method development/validation.
- Ability to work independently and manage multiple priorities to meet project timelines.
- Strong report writing and communication skills to liaise effectively with cross-functional teams.
- Experience supporting laboratory investigations, root cause analysis, and corrective actions.
- Familiarity with continuous improvement methodologies and audit support processes.
- Previous involvement in regulatory submission activities is desirable.
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