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Senior Director, Bioanalytical Research

Company: Lever
Location: Novato
Posted on: September 12, 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, Other , Novato, California

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