Associate Director/Director, Bioanalytical Laboratory

This role combines scientific depth, operational excellence, and people leadership. The Director will oversee assay development, validation, and execution for pharmacokinetic (PK) and anti-drug antibody (ADA) analyses supporting ADCs and other biologics, while building a high-performing team and fostering a culture of scientific rigor and continuous learning. This is a hands-on, high-impact role for a leader who thrives at the intersection of science, strategy, and mentorship.

Strategic & Scientific Leadership

• Define and execute bioanalytical strategies supporting discovery, preclinical, and clinical development of biologics and ADCs.
• Lead the design, development, validation, and troubleshooting of PK, ADA, and biomarker assays using ligand-binding, ELISA, ECLIA, LC-MS/MS, and hybrid methods.
• Serve as the bioanalytical lead in cross-functional project teams and regulatory interactions.
• Anticipate and adapt to evolving regulatory expectations and scientific advances to ensure SystImmune remains at the forefront of bioanalytical science.

Operational & Laboratory Management

• Oversee day-to-day laboratory operations to ensure compliance with GLP, GCP, ICH, and 21 CFR Part 11 standards.
• Direct equipment qualification, calibration, and maintenance programs.
• Establish and maintain SOPs, safety protocols, data integrity systems, and quality management processes.
• Partner with Quality Assurance to prepare for audits and regulatory inspections, maintaining a state of perpetual readiness.

Team Leadership & Talent Development

• Build, inspire, and empower a team of exceptional scientists and analysts.
• Foster a culture that emphasizes mentorship, growth, and scientific curiosity, helping staff expand their technical expertise and leadership potential.
• Create individualized development plans and cross-training opportunities to strengthen technical depth and career progression.
• Promote open communication, shared accountability, and recognition of high performance.

Cross-Functional & Global Collaboration

• Collaborate closely with Translational Sciences, Clinical Pharmacology, Regulatory Affairs, and Quality to ensure alignment on analytical strategy and regulatory submissions.
• Partner with global bioanalytical and translational teams to harmonize methods, data standards, and reporting practices.
• Represent SystImmune’s bioanalytical expertise in internal governance forums and external scientific networks.

Qualifications

• Ph.D. in Pharmacology, Biochemistry, Analytical Chemistry, Immunology, or related discipline (M.S. with significant experience considered).
• 10+ years of industry experience in bioanalytical sciences supporting biologics or ADC programs, including 5+ years in a leadership role.
• Demonstrated expertise in assay development, validation, and regulatory submission for PK/ADA/biomarker methods.
• Proven success managing GLP/GCP-compliant lab operations and preparing for health authority inspections.
• Strong understanding of global regulatory requirements (FDA, EMA, NMPA, ICH M10, E6).
• Exceptional leadership and people management skills with a record of developing scientific talent and fostering high-performance teams.
• Effective communicator who can translate complex data into strategic decisions.
• Experience managing CROs or global lab partnerships a plus.

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