Dir, Sr Director, Analytical Sciences / CMC
NWRPros, Seattle, WA, United States
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