Senior Biologics CMC & Analytical Strategy Lead

GTS Scientific; New York (NY); Hybrid; USD 210,000 - 260,000; Full time

Job summary

GTS Scientific in New York, NY is seeking a Director, Biologics CMC to lead analytical development for biologics programs from late discovery through clinical development. The role combines hands-on analytical work with strategic leadership across characterization, developability, manufacturing, quality, and regulatory CMC.

The position requires 8+ years of biologics analytical experience with deep expertise in MS, CE-SDS, icIEF, HPLC/UPLC, glycan analysis and cell-based potency assays.

Qualifications

• PhD or MS in Analytical Chemistry, Biochemistry, Biotechnology or related field.
• 8+ years of biologics development experience.
• Deep expertise in biologics analytical development.
• Experience with mass spectrometry, CE-SDS, icIEF, HPLC/UPLC, SEC, glycan analysis, binding and cell-based potency assays.
• Broad understanding of CLD, Upstream/Downstream Development, Formulation, Drug Product Manufacturing, Regulatory CMC, and CDMO management.

Responsibilities

• Lead analytical strategy for biologics characterization including method transfer, stability-indicating methods, potency and purity assays, identity testing, and impurities assessments.
• Serve as analytical CMC lead supporting developability assessment, IND-enabling activities, and lifecycle analytical strategy.
• Collaborate cross-functionally with Cell Line Development, Upstream, Downstream, Formulation, Drug Product Manufacturing, Quality, and Regulatory groups.
• Lead analytical activities with external laboratories and CDMOs; review protocols, validation reports and investigations.
• Support regulatory CMC sections, analytical justifications, comparability packages, and health authority responses.

Skills

Biologics analytical development

Mass spectrometry

CE-SDS

icIEF

HPLC/UPLC

Glycan analysis

Cell-based potency assays

Binding assays

Process development

Regulatory CMC

CDMO management

ICH analytical expectations

Upstream & Downstream

Lifecycle analytical strategy

Education

PhD or MS in Analytical Chemistry, Biochemistry, Biotechnology or related field

Job description

GTS Scientific in New York, NY is seeking a Director, Biologics CMC to lead analytical development for biologics programs from late discovery through clinical development. The role combines hands-on analytical work with strategic leadership across characterization, developability, manufacturing, quality, and regulatory CMC.

The position requires 8+ years of biologics analytical experience with deep expertise in MS, CE-SDS, icIEF, HPLC/UPLC, glycan analysis and cell-based potency assays.