Director, Biologics CMC (New York)
GTS Scientific
Director, Biologics CMC
(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 development
- Method qualification
- Method transfer
- Stability indicating methods
- Potency assays
- Purity assays
- Identity testing
- Process-related impurities
- Product-related impurities
- Reference standards
- Specification development
- Comparability assessments
Program Leadership
Serve as analytical CMC lead supporting:
- Candidate selection
- Developability assessment
- Preclinical development
- IND-enabling activities
- Clinical development
- 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
- Method lifecycle documentation
- 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
- Fc fusion proteins
- Novel biologics
Experience across multiple clinical stages preferred.
Vacancy posted 1 day ago
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