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Senior Director, Bioanalytical Research

Company: Lever
Location: Novato
Posted on: November 23, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • Independently lead and direct operations related to LC-MS/MS instrumentation, develop or optimize and implement LC-MS/MS analytical methods to separate, detect and quantify small molecules, nucleic acids (anti-sense oligonucleotides, siRNA, mRNA), macromolecules and biologics
  • Independently lead the development and implementation of novel and robust LC-MS/MS methods to quantify levels of novel compounds, test articles and metabolites in a variety of formulations and/or biological matrices
  • Lead development and optimization of upstream and downstream processes related to proteomics and large protein quantification.
  • Lead and develop scientific or experimental strategies to solve complex technical bioassay problems across the department.
  • Lead identification and evaluation of new technologies or instrumentation (i.e. imaging mass spectrometry) related to bioanalytical research and software applications
  • Effectively collaborate with the Drug Metabolism and Pharmacokinetic group to support metabolite profiling and identification for drug discovery and clinical evaluation using non-GLP bioanalytical analysis of samples from pharmacokinetic, toxicokinetic, and in vitro ADME and DDI studies
  • Ensure successful technology and method transfer of non-GLP bioanalytical assays for subsequent validation of nonclinical and clinical bioanalytical assays
  • Lead partnership with Lab Operations team to maintain and troubleshoot departmental HPLC, UPLC and MS instrumentation
  • Oversee and review technical reports for IND modules to support filing activities, patent applications and/or manuscripts/publications
  • Build, lead, supervise and mentor a core group of research associates and scientists to support bioanalytical research efforts
  • Set clear direction for direct reports aligned with functional and corporate goals. Reprioritize work, as needed. Support efficient decision making and collaboration with effective and proactive communication
  • Partner with CMC/Technical Operations, Quality and Lab Operation functions to assist in building lab networks across company sites and integrate bioanalytical methods related to mass spectrometry technologies
  • Lab / bench work related to the aforementioned responsibilities may be required when needed or as directed
  • PhD in scientific discipline and 15+ years' related industrial or academic experience (may include post-doctoral experience) or an MS in scientific discipline with 25+ years' related industrial or academic experience (may include post-doctoral experience)
  • Demonstrated leadership and significant experience developing, validating and optimizing quantitative LC-MS/MS bioanalysis and structure elucidation of small molecules, macromolecules and biologics in a drug discovery environment is required
  • Expertise in general computer software and data analysis software, including LC-MS/MS vendor specific instrument control and analysis tools, is required.
  • Experience writing SOPs, protocols and reports for bioanalytical studies is required
  • Proven experience managing and leading technical staff as well as mentorship is required
  • Strong interpersonal communication (verbal and written) and presentation skills is required
  • Proven ability to work in a multifunctional and highly-matrixed organization is required.
  • Experience establishing and/or managing bioanalytical research studies with external partners (industry or academic) and contract research organizations is required
  • Expertise in the identification of metabolites and metabolic pathways using mass spectrometry for pharmacokinetic studies is essential
  • Experience with ion chromatographic techniques is essential
  • Expertise with lab automation and/or robotic platforms such as a Hamilton, Biomek or Tecan is essential
  • Experience in the design and execution of in vitro ADME assays in collaboration with DMPK group to support drug discovery is essential
  • Knowledge of allied disciplines such as computer science, drug metabolism and pharmacokinetics related studies is desired
  • A record of accomplishments preparing and writing technical reports for regulatory documents (i.e INDs, CTAs) is essential
  • Experience in integrating various lab functions related to drug product manufacturing and QC/QA that requires bioanalytical techniques and instrumentation is desired
  • Experience or, at minimum, fundamental knowledge of nucleic acid (mRNA, siRNA, ASOs) and gene therapy platforms is desired
  • Experience of discovery and implementation of additional analytical techniques related to protein, nucleic acid and nanoparticle characterizations is desired
  • Experience developing or optimizing preclinical/research grade formulations such as lipid nanoparticles for nucleic acid drug discovery is desired

Keywords: Lever, Novato , Senior Director, Bioanalytical Research, Executive , Novato, California

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