Associate Director / Principal Scientist, Bioanalytical
- Employer
- Maze Therapeutics
- Location
- South San Francisco, CA, United States
- Start date
- Dec 2, 2020
View more
- Discipline
- Science/R&D, Bioanalytical Services, Biotechnology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Bay, NextGen Bio
Job Details
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
Company
Maze Therapeutics is translating novel genetic insights into lifesaving medicines, through an approach that integrates human genetics and functional genomics. Advances in these areas have enabled us to decode the mysteries of genetic modifiers in a range of severe diseases, which we aim to turn into medicines that mimic protective mutations.
What are genetic modifiers?
Despite an understanding of the genetic basis for many diseases, it remains a mystery why some people with a disease-causing mutation never get sick. This is often due to genes elsewhere in our DNA that affect the severity of disease and can provide a natural form of protection.
The Maze approach
Dramatic advances in human genetics and functional genomics now enable us to decode the mysteries of genetic modifiers in a range of severe diseases. Today, we believe we can systematically identify genetic modifiers and turn these insights into medicines. We have assembled a world-class team to realize this vision, including creative scientific pioneers, experienced company builders and biotech industry leaders.
Join us in our pursuit to change lives by translating genetic insights into medicine - view our job postings with the link to the left.
- Website
- https://mazetx.com/
- Location
-
171 Oyster Point Blvd, Suite 200
South San Francisco
CA
94080
United States
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