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