- 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
Principal Scientist Analytical Development and Support - Redmond, United States - Evotec
Description
Principal Scientist, Analytical Development and Support
Just-Evotec Biologics is seeking a motivated and creative Senior Scientist II/Principal Scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. The new hire will join a fast-paced, collaborative, and multidisciplinary team to build and lead a group to develop and execute separations methods for support of process development, cell line development, and release testing of biotherapeutics. As a Senior Scientist II/Principal Scientist in the Analytical Development and Support group, you will possess strong skills in H/UPLC and CE method development, method qualification, and large molecule characterization. Experience as a late stage analytical strategy lead with an understanding of comparability and/or similarity studies, participation in CMC teams, and authoring regulatory authority correspondence and interaction is preferred. The successful candidate will possess strong leadership and management skills. Experience with biosimilar development, liquid handling robotics, and leading CMC teams is strongly desired. The ideal candidate has strong written and verbal communications skills and works well independently and in teams.
Responsibilities:
Requirements:
Preferred qualifications:
The base pay range for this position at commencement of employment is expected to be $135,000 to $180,000; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.