Associate Director - IA

The Associate Director, Immunoassay - Method Development & Validation provides scientific and operational leadership for the development, optimization, validation, transfer, and execution of immunoassays supporting preclinical and clinical drug development programs. This role oversees a team of scientists responsible for ligand-binding assays (LBAs), biomarker assays, pharmacokinetic (PK), anti-drug antibody (ADA), neutralizing antibody (NAb), and cell-based immunoassays in a regulated Contract Research Organization (CRO) environment.

The Associate Director serves as a scientific subject matter expert and client-facing leader, ensuring delivery of high-quality bioanalytical data that complies with applicable regulatory requirements, including FDA, EMA, ICH, and GLP/GCP guidelines. The position drives scientific excellence, operational efficiency, and business growth while supporting strategic initiatives across multiple therapeutic areas.

Essential Duties and Responsibilities:

Scientific Leadership

• Lead the design, development, optimization, qualification, validation, and transfer of immunoassay methods for biologics, vaccines, cell and gene therapies, peptides, and biomarkers.
• Provide scientific oversight for PK, ADA, NAb, cytokine, biomarker, and receptor occupancy assay development projects.
• Evaluate novel technologies, platforms, and automation solutions to enhance laboratory capabilities.
• Review experimental designs, validation protocols, study plans, statistical analyses, and final reports.
• Troubleshoot complex technical challenges and provide strategic direction for assay performance improvements.
• Ensure bioanalytical methods are fit-for-purpose and aligned with regulatory expectations and client program requirements.
• Serve as scientific SME during client meetings, audits, inspections, and regulatory interactions.

Method Validation & Compliance

• Oversee assay qualification and validation activities in accordance with FDA, EMA, ICH, and industry guidance.
• Ensure validation parameters including accuracy, precision, selectivity, sensitivity, specificity, dilutional linearity, matrix effects, stability, and robustness meet acceptance criteria.
• Review and approve validation reports and technical documentation.
• Support regulatory inspection readiness and audit preparedness.
• Drive implementation of quality systems and continuous improvement initiatives.

Operational Management

• Direct day-to-day activities of immunoassay development and validation teams.
• Manage project timelines, resource allocation, instrumentation utilization, and laboratory capacity planning.
• Monitor project budgets and ensure delivery within scope, quality, and timeline commitments.
• Collaborate with Program Management to identify project risks and implement mitigation strategies.
• Establish operational metrics and monitor laboratory performance indicators.

Client Management & Business Development

• Act as primary scientific contact for sponsors throughout assay development and validation programs.
• Participate in proposal development, technical scoping, study design consultations, and bid-defense meetings.
• Support business development efforts by identifying new opportunities within existing and prospective client accounts.
• Present scientific capabilities and study results during client meetings and scientific conferences.
• Develop long-term client relationships to promote repeat business and strategic partnerships.

People Leadership

• Mentor, develop, and retain high-performing scientific staff.
• Establish performance objectives and provide ongoing coaching and development.
• Foster a collaborative, accountable, and scientifically rigorous laboratory culture.
• Support succession planning and technical competency development within the department.
• Lead cross-functional teams to achieve organizational objectives.

Required Qualifications

Education

• Ph.D. in Immunology, Biochemistry, Molecular Biology, Pharmaceutical Sciences, Bioanalytical Sciences, or related scientific discipline with 7+ years of relevant industry experience; OR
• Master's degree with 10+ years of relevant experience; OR
• Bachelor's degree with 12+ years of progressive experience in bioanalytical laboratory operations.

Experience

• Extensive experience in immunoassay method development and validation within a CRO, pharmaceutical, biotechnology, or bioanalytical laboratory environment.
• Demonstrated expertise in ligand-binding assays and biomarker assay development.
• Experience supporting regulated GLP, GCP, and/or CLIA laboratory environments.
• Previous people leadership experience including direct management of scientific teams.
• Strong client-facing experience managing complex sponsor relationships.
• Experience supporting regulatory inspections and client audits.

Technical Knowledge

Immunoassay Platforms

• ELISA
• MSD/ECL (Meso Scale Discovery)
• Gyrolab
• Luminex
• Quanterix Simoa
• Flow cytometry-based assays
• Cell-based bioassays
• Electrochemiluminescence immunoassays
• Multiplex biomarker platforms

Bioanalytical Applications

• Pharmacokinetic (PK) assays
• Anti-drug antibody (ADA) assays
• Neutralizing antibody (NAb) assays
• Biomarker assays
• Cytokine profiling
• Receptor occupancy assays
• Cell and gene therapy analytical support
• Vaccine immunogenicity testing

Regulatory Knowledge

• FDA Bioanalytical Method Validation Guidance
• EMA Bioanalytical Method Validation Guidance
• ICH Guidelines
• GLP/GCP requirements
• Data integrity standards (ALCOA+)
• 21 CFR Part 11

Competencies

• Scientific leadership and strategic thinking
• Strong analytical and problem-solving skills
• Excellent client relationship management
• Project and portfolio management expertise
• Regulatory and quality systems knowledge