- Support early stage, and late stage products in analytical sciences
- Lead analytical method development, validation, transfer and stability evaluations
- Vendor management and oversight of workflow as required
- Trouble-shooting of analytical methods
- Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences
- Author and/or review technical reports, test procedures, validation protocols and reports, and relevant sections of regulatory filings
- Support and ensure a smooth transfer of analytical technologies to contract sites
- Keep current with developments in analytical methodologies and make recommendations for implementation of new methods/equipment.
- Broad experience in analytical sciences supporting early stage, late stage biological therapeutic products
- Direct experience with analytical method development, validation, transfer and stability evaluations
- Familiarity with additional biophysical techniques used in protein characterization is required (iCIEF, CE-SDS,Size-Exclusion, reverse-phase UPLC).
- A comprehensive understanding of quality attributes, and protein degradation mechanisms as they relate to drug substance and drug product development and quality.
- Demonstrated technical proficiency of analytical methodologies for drug substance and drug product
- Experience in regulatory requirements for pharmaceutical products
- Experience in managing contract analytical organizations is desired
- Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills, including ability to lead and drive performance of cross-functional teams.
- Excellent written and verbal communication skills with ability to multi-task.
- Demonstrated troubleshooting and problem solving skills
Quality System Requirements:
- Current knowledge of quality systems and both FDA and EU regulations as they relate to process / product development and manufacturing
Qualifications and Experience:
- Advanced degree in Chemistry, Pharm. Sci., Biochemistry, or related field, or equivalent combination of education and work-related experience required
- 6-10 years direct experience analytical development, preferably in a pharmaceutical/biotech industry.
Job Type: Full-time