Senior Principal Scientist, Biologics Analytics

Upsher-Smith Laboratories, LLC; Rockville (MD); On-site; USD 142,000 - 200,000; Full time

Job summary

Upsher-Smith Laboratories, LLC in Rockville, MD is seeking a Principal Scientist, Analytical Sciences to lead analytical characterization for biologics across development stages. You will select methods, perform analyses, interpret results, and guide project teams toward commercialization.

You will supervise scientists, coordinate with CMC, ensure compliance with FDA/ICH guidelines, and contribute to regulatory submissions.

Qualifications

• PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences with 8+ years in industry (5+ in biologics).
• Alternatively, Master’s with 12+ years (8+ years in biologics) or Bachelor’s with 14+ years (10+ years in biologics).
• Minimum 2 years of direct people management experience.
• Extensive hands-on product characterization method development for biologics.
• Experience in analytical comparability studies and early- to late-stage activities.

Responsibilities

• Lead analytical characterization group and develop methods (UPLC, MS, HPLC, CE).
• Provide guidance on testing, reference materials, and comparability studies.
• Represent Analytical Sciences in CMC teams and align timelines.
• Develop control strategies per ICH/Regulatory guidance.
• Mentor and coach staff; drive on-time delivery.

Skills

Protein characterization methods

Analytical method development

Analytical comparability study design

Biologics experience

Leadership and mentoring

Regulatory documentation

Education

PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences

Master's degree with extensive experience in biologics

Bachelor's degree with significant experience in biologics

Tools

UPLC

MS

HPLC

CE-based methods

QA/QC instrumentation

Job description

Upsher-Smith Laboratories, LLC in Rockville, MD is seeking a Principal Scientist, Analytical Sciences to lead analytical characterization for biologics across development stages. You will select methods, perform analyses, interpret results, and guide project teams toward commercialization.

You will supervise scientists, coordinate with CMC, ensure compliance with FDA/ICH guidelines, and contribute to regulatory submissions.