Director, Biologics CMC

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

(Onsite 4 days in New York, New York, 1 day remote)

Position Summary

Reporting to the Head of CMC, the Director, Biologics CMC will lead CMC activities for biologics programs spanning late discovery through clinical development. The successful candidate will possess deep expertise in Biologics characterization and analytical development while maintaining broad knowledge across all biologics CMC disciplines including cell line development, process development, formulation, drug product manufacturing, quality, regulatory CMC, and external manufacturing.

This individual will be responsible for establishing analytical testing that support product quality, process development, clinical manufacturing, comparability, and regulatory submissions. As part of a lean organization, this role requires significant hands‑on technical involvement in addition to strategic leadership.

Primary Responsibilities

Analytical Leadership

Lead analytical strategy for:

• Product biophysical, chemical and biological characterization
• Method transfer
• Stability indicating methods
• Potency assays
• Purity assays
• Identity testing
• Process‑related impurities
• Product‑related impurities
• Reference standards
• Comparability assessments

Serve as analytical CMC lead supporting:

• Developability assessment
• IND‑enabling activities
• Lifecycle analytical strategy

Cross‑functional CMC Leadership

Collaborate closely with:

• Cell Line Development
• Upstream Development
• Downstream Development
• Formulation Development
• Drug Product Development
• Manufacturing
• Quality
• Regulatory

Provide scientific oversight across all CMC functions while serving as the analytical subject matter expert.

CDMO Management

• Lead analytical activities with external laboratories and CDMOs.
• Review development plans, protocols, validation reports and analytical investigations.
• Ensure analytical deliverables meet scientific and regulatory expectations.
• Drive issue resolution with external partners.

Regulatory Support

Contribute to:

• IND CMC sections
• Analytical justifications
• Comparability packages
• Health Authority responses
• Stability strategies

Required Qualifications

• PhD or MS in Analytical Chemistry, Biochemistry, Biotechnology or related field.
• Typically 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 assays
• Cell‑based potency assays
• Broad understanding of:
• CLD
• Upstream Development
• Downstream Development
• Formulation
• Drug Product Manufacturing
• Regulatory CMC
• Experience managing analytical CDMOs.
• Knowledge of ICH analytical expectations.

Preferred Experience

Experience supporting:

• Monoclonal antibodies
• Bispecific antibodies

Experience across multiple clinical stages preferred.