Associate director
Your Experience Includes…
- PhD in a biological or related discipline e.g., Biology, Biochemistry, Chemistry, Biotechnology or Pharmaceutical Science with 5+ years’ industry experience after postdoc.
- Experience in LC-MS based bioanalysis of proteins, oligos or small molecules is required.
- Excellent knowledge and hands-on experience in sample preparation techniques such as immuno-enrichment, beads extraction and LC/MS based method development and qualification/validation for proteins, oligos or small molecules.
- Proven ability to troubleshoot complex scientific challenges and manage multiple priorities.
- Deep understanding of the FDA/EMA regulatory requirements for bioanalytical and biomarker assays and current industry practices.
- Excellent organizational, communication and leadership skills.
- Proficiency of using Sciex Triple Quadrupole LC-MS/MS system and Thermo Orbitrap mass spectrometers such as Q Exactive series or Exploris series.
- Experience working in LNP-based gene therapy therapeutics is a plus.
- Experience with lab automation technologies is a plus.
- Experience in people management is a plus.
- Experience with downstream statistical and bioinformatics analysis is a plus.
- Develop, optimize, and validate bioanalytical methods to measure proteins, oligos, and lipids in biological samples, including cells, biofluids, and tissues, to support the development of preclinical and clinical programs.
- Lead a team of four PhD scientists conducting LC-MS analyses. Drive internal non-GLP bioanalytical activities to support PK, PK/PD and Biodistribution studies, ensuring timely project completion.
- Guide CROs to develop and validate LC-MS-based assays that support GLP toxicology studies, clinical bioanalytical measurements, and clinical biomarker readouts.
- Review and approve study plans, assay validation reports, and bioanalytical study reports. Author bioanalytical sections of regulatory submissions.
- Manage documentation of internal assay protocols, ROPs, qualification plans, and sample analysis reports.
- Collaborate with Formulation, Oligos Chemistry, Delivery, Pharmacology, Regulatory, Analytical Development and Platform teams to initiate and advance LC-MS assay work.
- Manage an LC-MS lab of four mass spectrometers, two Hamilton Stars and one Kingfisher Apex.
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