Sr Principal Scientist​/AD​/Director, Bioanalytical

Senior Principal Scientist / Associate Director / Director, Bioanalytical

Bioanalytical (BioA) – Senior Principal Scientist / Associate Director / Director

Location:

Seattle, WA (onsite)

Company:
Venture-backed biotech (stealth mode)

About the Company

Breakwater Therapeutics is an early‑stage, venture‑backed biotech operating in stealth mode. We’re building a nimble team that thrives in ambiguity, moves quickly from idea to experiment, and collaborates closely across science and operations to inform decision‑making.

The Opportunity

This is a foundational Bioanalytical (BioA) role responsible for establishing our in‑house ligand‑binding assay capabilities and leading the development and qualification of PK and ADA assays to support our antibody programs. You’ll drive assay strategy and execution from early method development through CRO transfer, setting high standards for data quality, reproducibility, and regulatory readiness.

This is a hands‑on position with significant cross‑functional visibility and long‑term potential for leadership as the company scales.

• 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 ligand‑binding 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 (ligand‑binding or cell‑based) 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 BLA‑enabling 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

• 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.

• Experience establishing new assay capabilities or standing up internal bioanalytical infrastructure.
• Familiarity with reagent generation and characterization (e.g., anti‑idiotypic antibody…