Principal Scientist, Biologics Analytics & Characterization

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

Job summary

Upsher-Smith Laboratories, LLC is seeking a Principal Scientist in Analytical Sciences to lead analytical characterization programs for biologics. You will design and implement methods (HPLC, mass spec, CE) and guide project teams through early to late-stage development, ensuring data quality and regulatory compliance.

You will supervise scientists, collaborate with CMC and other functions, and drive timely delivery of analytical deliverables while mentoring staff and shaping development

Qualifications

• PhD or equivalent with extensive biologics experience (8+ yrs).
• Experience leading analytical characterization programs.
• Strong background in regulatory-compliant method development.

Responsibilities

• Lead analytical characterization and CQA assessment for biologics.
• Oversee instrument maintenance and method validation.
• Collaborate with CMC teams to align analytical strategies.
• Mentor scientists and manage project timelines.
• Prepare technical documentation and regulatory submissions.

Skills

Protein characterization

Leadership

Analytical method development

Regulatory knowledge (ICH, FDA)

Scientific writing

Education

PhD in Biochemistry/Chemistry/Pharma

MS in Biochem/Chem/Pharma with 12+ yrs

BSc in Biochem/Chem/Pharma with 14+ yrs

Tools

HPLC

CE-based methods

UPLC

Mass spectrometry

Job description

Upsher-Smith Laboratories, LLC is seeking a Principal Scientist in Analytical Sciences to lead analytical characterization programs for biologics. You will design and implement methods (HPLC, mass spec, CE) and guide project teams through early to late-stage development, ensuring data quality and regulatory compliance.

You will supervise scientists, collaborate with CMC and other functions, and drive timely delivery of analytical deliverables while mentoring staff and shaping development