Director of Analytical Strategy & CMC Leadership

Work In Biotech LLC; Seattle (WA); Ibrido; USD 260.000 - 420.000; Tempo pieno

Descrizione del lavoro

Work In Biotech LLC is seeking an Analytical Development Lead at the Senior Director/Director level in Seattle (hybrid). You will define the analytical strategy across the monoclonal antibody program and oversee CDMO partners for method development, transfer, release, and stability activities.

The role requires a PhD with 12+ years in biopharma, hands-on biologics characterization, and proven leadership in regulatory interactions with FDA and other authorities.

Competenze

• PhD in analytical chemistry, biochemistry, biotechnology, or related field with 12+ years in biopharma.
• Extensive experience in analytical development and quality control for monoclonal antibodies.
• Expert in biologics characterization and release methods (chromatography, MS, bioassays).
• Experience managing CDMO relationships for method development and GMP release.
• Experience authoring analytical CMC sections of IND filings.
• Strong GMP, data integrity knowledge and ICH guidelines.
• Proven leadership of analytical teams and FDA interactions.

Mansioni

• Define and own phase-appropriate analytical strategy and control strategy across the pipeline.
• Lead product characterization and CQA assessment.
• Oversee method development, qualification, transfer, and data review.
• Coordinate CDMO/test labs, manage timelines and budgets.
• Regulatory documentation and interaction with health authorities.
• Plan transfers to Phase 3 manufacturing and late-stage readiness.
• Communicate risks and recommendations to leadership.

Conoscenze

Leadership

Analytical strategy

Cross-functional collaboration

Regulatory communication

Problem solving

Formazione

PhD in analytical chemistry/biochemistry

Descrizione del lavoro

Work In Biotech LLC is seeking an Analytical Development Lead at the Senior Director/Director level in Seattle (hybrid). You will define the analytical strategy across the monoclonal antibody program and oversee CDMO partners for method development, transfer, release, and stability activities.

The role requires a PhD with 12+ years in biopharma, hands-on biologics characterization, and proven leadership in regulatory interactions with FDA and other authorities.