Associate Director / Principal Scientist, Bioanalytical

Location
South San Francisco, CA, United States
Posted
Nov 03, 2020
Ref
4905988002
Required Education
Doctorate/PHD/MD
Position Type
Full time
We Are Genetic Navigators bringing together passionate, creative and dedicated professionals to join a rapidly-growing startup on our mission to translate novel genetic insights into lifesaving medicines. We are integrating human genetics and functional genomics to decode the mysteries of genetic modifiers, leading us to new medicines we'll develop for a range of severe diseases.

We are seeking a highly qualified Principal Scientist with a background in bioanalytical development and specific expertise in developing assays for detection of compound and biomarker activity. The successful candidate will work across project teams to drive bioanalytical strategy and execution for various programs, serving as the GLP lead. The Principal Scientist will develop bioanalytical methods that are fit-for-purpose (i.e., research, qualified, or validated) to support all Maze programs entering IND-enabling stages and beyond. Much of the wet-bench work will be conducted externally but will require expertise and willingness to directly tackle challenging bioanalytical issues in Maze laboratories as they arise. This person will grow to be the point of contact for assays as it relates to regulatory compliance aspects. The role is both hands-on and strategic in nature, developing technical method validations, managing work at CROs, and working collaboratively with existing internal DMPK expertise. The ideal candidate will have deep expertise in quantitative bioanalytical assays (at all levels of assay validation) as it relates to gene therapy and small molecular programs.

Your Role in Navigating The Maze:
  • Represent GLP/Bioanalysis in multiple cross-functional discovery project teams
  • Develop, implement, and execute complex quantitative assays to measure potency, biodistribution, immunogenicity, and pharmacodynamic studies in both nonclinical and clinical studies
  • Lead strategy of non-clinical and clinical bioanalytical assays and present findings to Project Teams
  • Serve as point of contact for assay validation and represent bioanalytical methods to various regulatory bodies
  • Manage bioanalytical CRO and ensure process transfer between groups and vendors is accurate
  • Maintain knowledge of current industry guidance for bioanalytical measurements

Your Navigation Tools:
  • PhD in a biological field with 6-8 years' experience in a bioanalytical role at an industry company
  • Thorough experience representing GLP and bioanalysis in cross-functional project teams
  • Deep expertise in bioanalytical methods and validations through industry or academic publishing
  • Experience developing bioanalytical assays for gene therapy and small molecule programs is highly preferred
  • Strong knowledge of industry and regulatory standards for quantitative measurements (PK/PD, biomarker, gene therapy biodistribution, immunogenicity)
  • Experience working with CROs on tech and process transfer
  • Highly motivated, self-starter with excellent written and verbal communication skills
  • A collaborative, communicative, and problem-solving disposition