Principal Scientist, Analytical Sciences

Job Description:

Principal Scientist, Analytical Development and Support

We are seeking a motivated and creative 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 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:

1. 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.
2. Collaborate across the organization to speed time to clinic while reducing development costs.
3. Serve as a technical resource on cross functional teams for separations methods.
4. Lead a team to develop, qualify, and document analytical methods.
5. Work with team members to support process development teams with high-throughput analytical procedures.
6. Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results.
7. Work with team members on technology development to reduce the cost and improve the efficiency, speed, and capacity of analytical testing and analytical methods.

Requirements:

1. BS/MS in Biochemistry, Biology, Bioengineering or related field with 15 years of experience or Ph.D. with 7 years of experience.
2. Expertise in the development and qualification and/or validation of H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF) methods.
3. Large molecule and protein characterization experience.
4. Experience with biosimilar development and biosimilarity studies.
5. Experience in CMC development teams.
6. Strong mentoring, managerial, and leadership skills.
7. Experience with early & late stage regulatory filings.
8. Leadership experience (2-5 people).

Preferred qualifications:

• 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.