Driven, detail-oriented scientist with over 25 years’ experience working with cGMP and GLP regulated products. Expert in the development, optimization, qualification, validation, transfer, implementation, routine testing, and review of analytical methods and their results.
Skills include:
- Building productive and lasting relationships with clients both internally and externally, nationally and internationally
- Expertise in collaborating across functions including: Business Development, Program Management, Research and Development, Operations, Quality Control, Quality Assurance, and Regulatory Affairs
- Expert in the development, optimization, qualification, validation, transfer, implementation, routine testing, and review of analytical methods and their results
- Proficient in completing compliant SOPs, technical reports, validation protocols and reports, regulatory submission documents for FDA and EMA
- Demonstrated ability to manage multiple projects and priorities with exceptional organizational and time management skills: Setting and meeting deadlines, and staying on budget
