Associate Director / Director, Bioanalytical Laboratory

Position Summary
SystImmune is seeking an Associate Director or Director of Bioanalytical Laboratory to lead U.S.-based bioanalytical functions supporting our global clinical development programs, with a particular focus on pharmacokinetics (PK) and anti-drug antibody (ADA) analysis for ADCs and other biotherapeutics.
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.
Key Responsibilities
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
Education

• 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.

Experience

• 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.

Skills

• 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.