ZipRecruiter
Associate Director / Director, Bioanalytical Laboratory
ZipRecruiter, Princeton, New Jersey, us, 08543
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 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 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 supporting preclinical and clinical development of ADCs and 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 project teams. Laboratory & Facility Oversight
Oversee daily operations of the Bioanalytical Lab, ensuring compliance with GLP, GCP, ICH, and internal standards. Manage equipment calibration, qualification, and maintenance. Develop SOPs, training programs, safety protocols, and quality systems for inspection readiness. Lead internal audits and inspections by health authorities. Team & Program Management
Build, lead, and mentor scientists and technical staff; manage performance and career development. Oversee resource allocation, project timelines, and data quality for regulatory and clinical milestones. Promote a culture of accountability, scientific rigor, and continuous improvement. Global and Cross-functional Collaboration
Coordinate with global bioanalytical and translational teams to align strategies and data standards. Collaborate with Clinical Development, Regulatory, Quality Assurance, and other stakeholders for submissions. Participate in initiatives to harmonize bioanalytical practices and data reporting. Regulatory & Quality Responsibilities
Author and review bioanalytical sections of regulatory submissions (e.g., INDs, BLAs, CTAs). Ensure compliance with FDA, EMA, NMPA, ICH guidelines. Support regulatory inspections and address inquiries related to bioanalytical methods and data integrity. Qualifications
Education Ph.D. in Pharmacology, Biochemistry, Analytical Chemistry, or related field, or M.S. with extensive industry experience (12+ years). Experience Minimum 10 years in bioanalytical sciences, with 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. Expertise in method development, validation, troubleshooting for PK/ADA assays. Experience managing GLP/GCP-compliant labs and CAPA systems. Knowledge of data integrity principles (21 CFR Part 11) and equipment qualification. Skills
Strong leadership and team-building skills. Technical expertise in ligand-binding assays, LC-MS/MS, immunoassays, and hybrid methods. Excellent communication skills for cross-functional and cross-cultural collaboration. Proficiency in regulatory documentation and audit readiness. Adaptability in fast-paced, mission-driven environments.
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Associate Director or Director of Bioanalytical Laboratory
to lead U.S.-based bioanalytical functions supporting our global clinical development programs, with a 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 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 supporting preclinical and clinical development of ADCs and 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 project teams. Laboratory & Facility Oversight
Oversee daily operations of the Bioanalytical Lab, ensuring compliance with GLP, GCP, ICH, and internal standards. Manage equipment calibration, qualification, and maintenance. Develop SOPs, training programs, safety protocols, and quality systems for inspection readiness. Lead internal audits and inspections by health authorities. Team & Program Management
Build, lead, and mentor scientists and technical staff; manage performance and career development. Oversee resource allocation, project timelines, and data quality for regulatory and clinical milestones. Promote a culture of accountability, scientific rigor, and continuous improvement. Global and Cross-functional Collaboration
Coordinate with global bioanalytical and translational teams to align strategies and data standards. Collaborate with Clinical Development, Regulatory, Quality Assurance, and other stakeholders for submissions. Participate in initiatives to harmonize bioanalytical practices and data reporting. Regulatory & Quality Responsibilities
Author and review bioanalytical sections of regulatory submissions (e.g., INDs, BLAs, CTAs). Ensure compliance with FDA, EMA, NMPA, ICH guidelines. Support regulatory inspections and address inquiries related to bioanalytical methods and data integrity. Qualifications
Education Ph.D. in Pharmacology, Biochemistry, Analytical Chemistry, or related field, or M.S. with extensive industry experience (12+ years). Experience Minimum 10 years in bioanalytical sciences, with 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. Expertise in method development, validation, troubleshooting for PK/ADA assays. Experience managing GLP/GCP-compliant labs and CAPA systems. Knowledge of data integrity principles (21 CFR Part 11) and equipment qualification. Skills
Strong leadership and team-building skills. Technical expertise in ligand-binding assays, LC-MS/MS, immunoassays, and hybrid methods. Excellent communication skills for cross-functional and cross-cultural collaboration. Proficiency in regulatory documentation and audit readiness. Adaptability in fast-paced, mission-driven environments.
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