Associate Director – Bioanalytical

Associate Director – Bioanalytical

Requirements

• Hand-on technical experience in bioanalytical assay development, validation and sample analysis, including (but not limited to) PCR, RT-PCR, bDNA, LBA, ELISPOT etc spanning from Research to Development phases
• Proficient knowledge and experience of bioanalytical assay requirements and submission standards per regulatory guidelines
• Excellent organizational skills and documentation practices
• Excellent communication skills with ability to build open and collaborative relationships and work effectively as a member of multidisciplinary teams
• Experience with working in a collaborative team environment and with CROs to oversee assay transfer, troubleshooting, assay development/validation and sample testing
• Previous work experience in GLP environment is a plus
• Master’s (M.S) degree in biochemistry, cell biology, or related discipline with 8+ years working experience in biotech or pharmaceutical industry or, PhD degree with 6+ years working experience in a related discipline

Responsibilities

• Design and perform bioanalytical assay development, including quantitation of DNA/RNA and immunogenicity evaluations for cell and gene therapies
• Supervise junior scientists by providing scientific and technical leadership to bioanalytical assay development/qualification and analysis of study samples
• Evaluate novel platforms or technologies to enhance DMPK-Bioanalysis capabilities
• Collaborate with cross functional teams to design and execute bioanalytical studies
• Responsible for conducting or supervising internal and external bioanalytical assays in support of preclinical and clinical studies, and ensure alignment with industry standard practice and regulatory expectations

Preferred Qualifications

• Previous work experience in GLP environment is a plus