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
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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
#J-18808-Ljbffr