Associate Director / Director, Bioanalytical Laboratory – Translational Sciences Division

The role, based in Redmond, WA, involves strategic leadership of laboratory operations, scientific oversight of method development and validation, regulatory compliance management, and close collaboration with cross-functional and international teams, especially in China.

This is a high-impact, hands-on leadership position requiring deep scientific expertise, regulatory knowledge, operational excellence, and strong communication skills.

Strategic & Scientific Leadership

• Develop and execute bioanalytical strategies to support preclinical and clinical development of ADCs and other biologics.
• Lead development, optimization, and validation of bioanalytical methods (e.g., ELISA, ECLIA, LC-MS/MS, ligand-binding assays) for PK, ADA, and other biomarkers.
• Represent Bioanalytical Sciences in regulatory meetings and cross-functional project teams.

Laboratory & Facility Oversight

• Oversee day-to-day operations of the Bioanalytical Lab, ensuring compliance with GLP, GCP, ICH, and internal quality standards.
• Ensure equipment calibration, qualification, and maintenance are performed according to validated procedures.
• Develop and implement SOPs, training curricula, safety protocols, and quality systems to maintain inspection readiness.
• Lead preparation and execution of internal audits and inspections by health authorities.

Team & Program Management

• Build, lead, and mentor a team of scientists and technical staff; manage performance reviews and career development plans.
• Oversee resource allocation, project timelines, and delivery of high-quality data for regulatory and clinical milestones.
• Foster a culture of accountability, scientific rigor, and continuous improvement.

Global and Cross-functional Collaboration

• Coordinate with global bioanalytical and translational science teams to align platforms, analytical strategies, and data standards.
• Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, and other stakeholders to support clinical and regulatory submissions.
• Participate in global initiatives to improve harmonization of bioanalytical practices and data reporting.

Regulatory & Quality Responsibilities

• Author and review bioanalytical sections of regulatory submissions (e.g., INDs, BLAs, CTAs).
• Ensure compliance with international regulatory requirements including FDA, EMA, NMPA, and ICH guidelines (e.g., ICH E6, E14, M10).
• Lead or support regulatory inspections, addressing inquiries related to bioanalytical methods, data integrity, and laboratory operations.

Qualifications

• Ph.D. in Pharmacology, Biochemistry, Analytical Chemistry, or a related field is preferred.
• M.S. with extensive industry experience (12+ years) will also be considered.
• Minimum 10 years of industry experience in bioanalytical sciences, with direct involvement in clinical-stage biologics or ADC development.
• At least 5 years of leadership experience in a laboratory setting, preferably at the Associate Director level or higher.
• Proven expertise in method development, validation, and troubleshooting for PK/ADA assays.
• Hands-on experience managing GLP/GCP-compliant labs and implementing CAPA systems.
• Working knowledge of data integrity principles (21 CFR Part 11) and equipment/facility qualification.
• Strong leadership and team-building abilities; capable of fostering high-performance teams.
• In-depth technical expertise in ligand-binding assays, LC-MS/MS, immunoassays, and hybrid methodologies.
• Excellent communication skills with demonstrated success in cross-functional and cross-cultural collaborations.
• Proficiency in regulatory documentation and audit preparedness.
• Ability to work in a dynamic, fast-paced, and mission-driven environment with shifting priorities.