Breakwater Therapeutics · 2 months ago
Senior Principal Scientist / Associate Director / Director, Bioanalytical
Seattle, WA
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expBreakwater Therapeutics is an early-stage, venture-backed biotech operating in stealth mode. This foundational Bioanalytical role is responsible for establishing in-house ligand-binding assay capabilities and leading the development and qualification of PK and ADA assays to support antibody programs.
Biotechnology
Responsibilities
Build & run BioA capability
Define BioA strategy across nonclinical and clinical stages; align plans with program milestones
Establish internal workflows, acceptance criteria, reference standards, bridging/lottolot strategies, sample tracking (ELN/LIMS), and data QC
Author SOPs and fitforpurpose qualification/validation plans consistent with ICH and relevant guidance
Design and develop antiidiotypic ligandbinding assays (e.g., ELISA, MSD) to quantify program antibodies in relevant matrices
Leverage biophysical tools (e.g., SPR, BLI) for reagent selection/characterization and to understand binding kinetics/epitope coverage
Establish assay performance characteristics (specificity, selectivity, dilution linearity, precision/accuracy, hook/drug tolerance, stability) and qualify/validate as appropriate
Develop an antiidiotypic control method to quantify a marketed antibody in NHP and human matrices to support comparative PK
Build tiered ADA methods (screen/confirm/titer) with appropriate cutpoint determination, tolerance assessments, and confirmatory competition
Design and qualify neutralizing antibody (NAb) assays (ligandbinding or cellbased) as needed for risk assessment
Define sampling plans, data review criteria, and reporting conventions for nonclinical and clinical studies
Author method transfer packages; conduct onsite/remote transfers, training, and readiness reviews
Select and manage CROs, negotiate scopes/timelines, and oversee study execution, data QC, deviations/CAPAs, and audit preparedness
Ensure data packages and certificates meet regulatory expectations for inclusion in regulatory submissions
Write and review method development reports, qualification/validation reports, and bioanalytical sections of regulatory filings (e.g., IND/CTA; contribute to BLAenabling documentation)
Provide concise data summaries and recommendations to senior leadership; present at internal governance
Partner with Discovery, Protein Sciences, Nonclinical, Clinical, and CMC to align materials, timelines, and decision points
As the team grows, mentor/lead 1–2 RAs/Scientists while remaining a hands on contributor
Qualification
Required
Ph.D. (or equivalent) in Analytical Chemistry, Molecular Biology, Pharmaceutics, or a related field
5+ years of relevant industry experience in ligand-binding bioanalytical method development for monoclonal antibodies, including first IND and BLA participation
Hands-on expertise with ligand-binding assay platforms (ELISA, MSD, BLI, SPR)
Demonstrated experience developing and qualifying ADA and NAb assays
Proven success with in-house assay development and subsequent tech transfer to CROs
Strong knowledge of regulatory expectations (ICH, FDA guidance) for bioanalytical method validation
Preferred
Experience establishing new assay capabilities or standing up internal bioanalytical infrastructure
Familiarity with reagent generation and characterization (e.g., anti-idiotypic antibody screening and qualification)
Working knowledge of bioanalytical support for both preclinical (NHP) and clinical PK studies
Strong vendor management skills and experience authoring CRO study plans and data QC packages
Experience contributing to regulatory submissions and responding to bioanalytical queries
Company
Breakwater Therapeutics
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase