The Role
Lead analytical development including method development/validation, method transfers, stability and formulation testing, instrument qualification, GMP documentation, stability program management, COA generation, and support to regulatory and project teams.
Summary Generated by Built In
Job Summary
- Accepts responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing, etc.
- Performs validations or verification of methods including transfer of methods to Quality Technologies or Quality Control or other testing laboratory.
- Review and approve Validation protocol/report, data packages, SOPs and other Laboratory documentation.
- Manages stability program by execution of stability testing protocols, testing logistics for laboratory, providing stability summaries, finished product COA generation and provides updates to Regulatory Affairs and project team.
- Support Laboratory operation for instrument qualification.
- Ensures all technologies needed are available for project completion.
- Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in analytical method development, validation, and testing.
- Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results to resolve problems.
- Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements.
- Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule.
- Requires an eye for detail and repetitive precision in lab work and documentation.
Skills Required
- Analytical method development and validation
- Method transfer to Quality Technologies, Quality Control, or other testing laboratories
- Review and approval of validation protocols/reports, data packages, SOPs, and laboratory documentation
- Manage stability program execution, testing logistics, stability summaries, and finished product COA generation
- Support laboratory instrument qualification and ensure necessary technologies are available
- Design and implement well-controlled experimental programs
- GMP-compliant recording of experimental procedures, results, and observations
- Identify problems and recommend scientific alternatives and priorities to resolve issues
- Establish work priorities and keep assignments on schedule
- High attention to detail and precision in lab work and documentation
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The Company
What We Do
Fresenius is a global healthcare company headquartered in Germany, dedicated to saving and improving human lives through affordable and innovative healthcare products and high-quality clinical care. The company focuses on three key therapy platforms: (Bio)Pharma, MedTech, and Care Provision, providing system-critical products and services for the treatment of critically and chronically ill patients worldwide.
