Director, Bioanalytical Sciences — PK/Immunogenicity Lead
Real Staffing Group
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Job summary
Mentari Therapeutics is seeking an Associate Director/Director of Bioanalytical Sciences to design and execute strategies supporting development programs. This hands-on, leadership-focused role oversees CRO partners and internal assays for PK, ADA, nAb, and biomarker analyses, ensuring compliance in GLP/GCLP environments.
The successful candidate will manage study timelines, budgets, and data integrity while collaborating with translational and clinical science teams to deliver high-quality,
Qualifications
- BS with 10+ years in Bioanalytical Sciences or related field
- MS with 8+ years in industry/CRO
- PhD with 5+ years in bioanalytical sciences or biotech milieu
Responsibilities
- Lead bioanalytical strategy for clinical and nonclinical programs
- Oversee CROs: timelines, budgets, quality and compliance
- Direct development, validation, and sample analysis for PK/TK, ADA, nAb, and biomarkers
- Provide oversight of assays in GLP/GCLP environments
- Review validation protocols and data, ensuring data integrity and regulatory readiness
- Collaborate with cross-functional teams to align strategy and study execution
- Author reports and support regulatory submissions related to bioanalysis
Skills
Education
Tools
Job description
Mentari Therapeutics is seeking an Associate Director/Director of Bioanalytical Sciences to design and execute strategies supporting development programs. This hands-on, leadership-focused role oversees CRO partners and internal assays for PK, ADA, nAb, and biomarker analyses, ensuring compliance in GLP/GCLP environments.
The successful candidate will manage study timelines, budgets, and data integrity while collaborating with translational and clinical science teams to deliver high-quality,
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