What are the responsibilities and job description for the Associate Director position at BioLegacy Research?
Position Overview
We are seeking an experienced scientific leader to serve as Associate Director, In Vitro Bioanalysis, supporting the development and growth of a high-impact bioanalytical platform across pharmacokinetic (PK), toxicokinetic (TK), biomarker, and immunogenicity assays.
This individual will provide scientific and operational leadership for in vitro bioanalysis activities supporting preclinical and clinical programs, ensuring delivery of high-quality data under GLP and non-GLP environments.
The Associate Director will play a key role in advancing bioanalytical capabilities, guiding assay development, and supporting client programs, while partnering closely with senior leadership on broader scientific and organizational direction.
Key ResponsibilitiesScientific Leadership and Strategy
Education
We are seeking an experienced scientific leader to serve as Associate Director, In Vitro Bioanalysis, supporting the development and growth of a high-impact bioanalytical platform across pharmacokinetic (PK), toxicokinetic (TK), biomarker, and immunogenicity assays.
This individual will provide scientific and operational leadership for in vitro bioanalysis activities supporting preclinical and clinical programs, ensuring delivery of high-quality data under GLP and non-GLP environments.
The Associate Director will play a key role in advancing bioanalytical capabilities, guiding assay development, and supporting client programs, while partnering closely with senior leadership on broader scientific and organizational direction.
Key ResponsibilitiesScientific Leadership and Strategy
- Contribute to scientific direction for bioanalytical assay development supporting PK, TK, biomarker, and immunogenicity analyses
- Provide scientific guidance on immunogenicity risk assessment and ADA assay strategies
- Lead design, development, optimization, and validation of bioanalytical methods for biologics and small molecules
- Support continuous improvement and expansion of in vitro bioanalytical capabilities
- Provide technical mentorship and guidance to scientists on assay development and troubleshooting
- Oversee development and validation of GLPcompliant PK assays supporting preclinical and clinical studies
- Guide development and validation of immunogenicity assays, including ADA screening, confirmatory, titer, and neutralizing antibody (NAb) assays
- Ensure methods meet regulatory expectations for accuracy, precision, sensitivity, and robustness
- Review and contribute to method validation reports, study reports, and regulatory documentation
- Ensure laboratory activities comply with GLP, GxP, and applicable regulatory standards (FDA, ICH, OECD)
- Support preparation for regulatory inspections and client audits
- Partner with Quality Assurance (QA) to maintain compliant systems and documentation
- Contribute to development and maintenance of SOPs, validation plans, and quality systems
- Provide leadership and mentorship to scientists and technical staff
- Support team development, training, and performance management
- Contribute to resource planning and prioritization of laboratory activities
- Foster a collaborative and scientifically rigorous team environment
- Provide scientific oversight for bioanalytical components of GLP and nonGLP studies
- Collaborate with pharmacology, toxicology, DMPK, and translational teams
- Ensure bioanalytical deliverables meet internal and client expectations
- Serve as a scientific point of contact for client programs
- Provide technical input on assay development and study design
- Support client discussions, presentations, and program alignment
- Contribute to proposal development and technical materials as needed
Education
- PhD in Immunology, Pharmacology, Toxicology, Bioanalytical Science, or related discipline
- 12 years of experience in bioanalysis, PK assay development, or related fields
- Strong experience operating in GLPregulated environments
- Demonstrated experience leading scientific projects and mentoring teams
- Experience supporting regulated studies and data packages
- PK assay development and validation
- Immunogenicity assay development (ADA, NAb, etc.)
- GLP bioanalytical laboratory operations
- Ligandbinding assays (ELISA, MSD), LCMS/MS, flow cytometry, cellbased assays
- Bioanalytical method validation and reporting
- Experience supporting biologics or advanced modalities (cell & gene therapy)
- CRO experience supporting multiple client programs
- Experience contributing to expansion of laboratory capabilities
- Opportunity to play a key role in advancing a growing bioanalytical platform
- Work with innovative biopharma partners across diverse programs
- Collaborative environment with strong scientific leadership
- Ability to make meaningful impact on study execution and scientific delivery