Principal Scientist Analytical Development and Support
3 weeks ago
- Analytical team lead/CMC lead
- Build and lead a diverse group encompassing all aspects of separations methods development and high throughput support, qualification/validation of methods, and tech transfer to Quality Control
- Collaborate across the organization to speed time to clinic while reducing development costs
- Manage staff
- Serve as a technical resource on cross functional teams for separations methods
- Lead a team to develop, qualify, and document analytical methods
- Work with team members to support process development teams with high-throughput analytical procedures
- Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results
- Work with team members on technology development to reduce the cost and improve the efficiency, speed, and capacity of analytical testing and analytical methods
- Supervise and mentor Scientists and Associates
- BS/MS in Biochemistry, Biology, Bioengineering or related field with 15+ years of experience or Ph.D. with 7+ years of experience.
- Expertise in the development and qualification and/or validation of H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF) methods
- Large molecule and protein characterization experience
- Experience with biosimilar development and biosimilarity studies
- Experience in CMC development teams as an Analytical Lead
- Strong mentoring, managerial, and leadership skills
- Strong oral and written communication skills
- Experience with early & late stage regulatory filings
- Experience in Team management (3-5 people) & Leadership
- Use of liquid-handling automation applications
- Experience with troubleshooting complex instrumentation
- Direct interactions with FDA and other regulatory agencies
- Knowledge of mass spectrometry methods
- Characterization of complex Glycoproteins
- Experience with compendial assays (USP, EP, JP)
- Strength in data science and informatics
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