Principal Scientist/Associate Director: Bioanalytical Science

Q32 BIO is advancing novel therapeutics to treat serious autoimmune and inflammatory disorders. We aim to deliver life-changing treatments for patients with a variety of diseases for whom no adequate treatment options exist.

General Scope and Summary

Q32 Bio is searching for an independent, collaborative preclinical and clinical stage programs.

This position will report to the Senior Director Nonclinical Development.

This principal scientist/associate director will serve as the lead scientist for study bioanalysis supporting early research programs through clinical trials. Individually and through CROs or direct reports, this person will be responsible for bioanalytical and immunogenicity assay development, assay qualification and validation, sample analysis, data interpretation, and delivery of results and reports. The role will have close interactions across functions to ensure successful execution of nonclinical and clinical programs.

• Roles and Responsibilities
  Oversee pharmacokinetic and immunogenicity sample analysis from preclinical and clinical studies and review resulting data to ensure the quality and integrity of data.
• Prepare and review sample analysis documentation, nonclinical bioanalytic reports, and clinical sample analysis reports.
• Serve as point of contact for external bioanalytical CROs to ensure execution of project goals.
• Contribute to design of non-GLP, GLP, and clinical studies to ensure that bioanalytical endpoints are appropriately incorporated.
• Interface with stakeholders including nonclinical development, clinical development team, and external CROs to define and deliver upon strategies to support project timelines across multiple projects.
• Author documents and contribute to submission teams supporting First-in-Human through Biologics License Application (BLA) studies.

Qualifications

• PhD >5 years of experience in life sciences or equivalent experience; or a minimum of 12 years of experience performing progressively advanced duties beyond a B.S. degree,
• Subject matter expert with extensive hands-on experience developing pharmacokinetics (PK), immunogenicity, and neutralizing antibody (Nab) assays to support large molecule therapeutics.
• Strong experience with assay development, transfer, qualification, and validation to external partners (CROs/CMOs) in a GLP/GxP environment.
• Familiar with bioanalytical regulatory guidance and industry standard practice for conducting clinical bioanalysis highly preferred.
• In-depth knowledge of the biologic drug development process from drug discovery to biologics license application.
• Experience writing/reviewing study reports and contributing to regulatory submissions
• Strong project management and interpersonal skills
• Demonstrated attention to detail with a track-record of scientific productivity (e.g., successful drug-discovery project support)
• Ability to work independently in a fast-paced, collaborative team environment

Interested parties should send their CV to talent@q32bio.com