Commercial Readiness | Biologics & Small Molecules | Analytical Strategy
Position Overview
A Seattle biopharmaceutical company is seeking an accomplished Analytical Sciences leader to drive CMC analytical strategy across development and commercial programs. This role requires a deeply experienced technical authority capable of establishing robust, inspection-ready analytical frameworks with immediate impact.
The successful candidate will bring significant biologics expertise, with additional experience in small molecule programs preferred. This role demands a seasoned leader who can independently define analytical specifications, oversee product characterization, and ensure commercial-grade robustness in release and stability programs.
This is a critical leadership position within a growing organization operating with lean resources — requiring immediate subject matter expertise and high reliability.
Core Responsibilities
Analytical & CMC Leadership
- Establish and oversee drug substance and drug product specifications
- Lead analytical method development, qualification, validation, and lifecycle management
- Direct product characterization, critical quality attribute assessments, and comparability strategies
- Define analytical strategy supporting IND, BLA, and NDA submissions
- Ensure commercial readiness of release and stability methods
Operational & Organizational Leadership
- Lead and mentor a growing analytical sciences team
- Oversee timelines, budgets, and resource planning
- Drive analytical priorities aligned with CMC and corporate objectives
- Support commercial launch preparation and lifecycle management activities
- Contribute to third-party contract negotiations and supply agreements
External Collaboration & Regulatory
- Oversee analytical method transfer and validation at CMOs
- Review and approve protocols, reports, and investigations
- Lead analytical contributions to regulatory filings and agency interactions
- Ensure global regulatory compliance and inspection readiness
Required Background
- PhD (strongly preferred) or MD in Analytical Chemistry, Biochemistry, Biology, or related scientific field
- 15+ years of analytical sciences and CMC leadership experience in biotech/pharma
- Deep expertise in biologics; small molecule analytical experience desirable
- Demonstrated experience supporting commercial-stage products
- Strong knowledge of GMPs, comparability protocols, and regulatory CMC requirements
- Experience with complex modalities (e.g., conjugates, oncology-related platforms, integrated biologic systems) highly desirable
- Experience in highly technical, science-driven organizations (large pharma or advanced biotech environments preferred)
Leadership Profile
- Technical authority capable of operating independently with minimal onboarding
- “Hard-core” CMC mindset — focused on robustness, reproducibility, and regulatory defensibility
- High standards around quality, reliability, and scientific excellence
- Strong executive communication skills
- Comfortable building infrastructure in resource-constrained environments
Additional Information
- On-site presence strongly preferred
- Limited travel (~10%)
- Relocation may be considered