Director of Analytical Development (Late Stage), Biologics
Director of Analytical Development, Biologics
REMOTE - East Coast Based Preferred
Overview
We are partnering with a clinical-stage (late-stage) biopharmaceutical organization seeking a Director of Analytical Development to lead analytical strategy and execution for biologics programs advancing through late-stage development, BLA readiness, and commercialization.
This individual will play a critical role in method lifecycle management, regulatory submissions, and commercial readiness, working cross-functionally across CMC, Quality, and Regulatory.
This is a fully remote role (U.S.-based).
Key Responsibilities
- Lead analytical development strategy for late-stage biologics programs, including Phase II/III and commercial readiness
- Oversee method validation, transfer, and lifecycle management in alignment with ICH guidelines (Q2, Q6, Q14)
- Drive analytical support for regulatory submissions, including IND amendments, BLA/MAA filings, and responses to health authority questions
- Partner with Drug Substance, Drug Product, and Quality teams to ensure robust control strategies and specifications
- Provide oversight of CDMOs and external testing laboratories, ensuring timelines, data quality, and compliance
- Support comparability, stability, and characterization strategies for process changes and scale-up
- Act as a key contributor during inspections and audits (FDA, EMA, etc.)
- Build, mentor, and scale a high-performing analytical team as programs advance toward commercialization
Qualifications
- PhD (preferred) or MS in Analytical Chemistry, Biochemistry, or related field
- ~10-15+ years of analytical development experience in biologics (monoclonal antibodies, proteins, or related modalities)
- Strong expertise in late-stage development, method validation, and regulatory filings (BLA/MAA)
- Deep knowledge of analytical techniques (e.g., HPLC/UPLC, CE, MS, bioassays, impurity profiling)
- Proven experience managing external partners (CDMOs/CROs)
- Familiarity with global regulatory expectations and inspection readiness
- Prior leadership experience with the ability to influence cross-functional stakeholders
What Stands Out
- Opportunity to shape analytical strategy at a pivotal, late-stage inflection point
- High visibility role with direct impact on regulatory approval and commercialization
- Fully remote flexibility with strong cross-functional exposure
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