gts scientificNew York, NY
Director, Biologics CMC (New York)
Director, Biologics CMC (New York)
Director, Biologics CMC (New York)
gts scientificNew York, NY
today
Research and Development in BiotechnologyBiological Product ManufacturingIn-Vitro Diagnostic Substance Manufacturing
Apply for this role (opens in a new tab)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 developmentIND-enabling activities
- Clinical development
- Lifecycle analytical strategy
- Cross-functional CMC Leadership
- Collaborate closely with:
- Cell Line Development
- Upstream DevelopmentDownstream Development
- Formulation Development
- Drug Product Development
ManufacturingQualityRegulatoryProvide 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 spectrometryCE-SDSicIEFHPLC/UPLCSECGlycan analysis
- Binding assays
- Cell-based potency assays
- Broad understanding of:
- CLDUpstream DevelopmentDownstream Development
- FormulationDrug Product Manufacturing
- Regulatory CMCExperience 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.
Also on the board Same function, level within a rung
Level
Manager
Location
New York, NY
Occupation
Natural Sciences Managers
Industry
Research and Development in Biotechnology
Posted
today