Director / Senior Director, Analytical Development

Work In Biotech; Seattle (WA); Hybrid; USD 260,000 - 420,000; Full time

Job summary

Work In Biotech LLC is seeking an Analytical Development Lead at the Senior Director/Director level in Seattle (hybrid). You will define the analytical strategy across the monoclonal antibody program and oversee CDMO partners for method development, transfer, release, and stability activities.

The role requires a PhD with 12+ years in biopharma, hands-on biologics characterization, and proven leadership in regulatory interactions with FDA and other authorities.

Qualifications

• PhD in analytical chemistry, biochemistry, biotechnology, or related field with 12+ years in biopharma.
• Extensive experience in analytical development and quality control for monoclonal antibodies.
• Expert in biologics characterization and release methods (chromatography, MS, bioassays).
• Experience managing CDMO relationships for method development and GMP release.
• Experience authoring analytical CMC sections of IND filings.
• Strong GMP, data integrity knowledge and ICH guidelines.
• Proven leadership of analytical teams and FDA interactions.

Responsibilities

• Define and own phase-appropriate analytical strategy and control strategy across the pipeline.
• Lead product characterization and CQA assessment.
• Oversee method development, qualification, transfer, and data review.
• Coordinate CDMO/test labs, manage timelines and budgets.
• Regulatory documentation and interaction with health authorities.
• Plan transfers to Phase 3 manufacturing and late-stage readiness.
• Communicate risks and recommendations to leadership.

Skills

Leadership

Analytical strategy

Cross-functional collaboration

Regulatory communication

Problem solving

Education

PhD in analytical chemistry/biochemistry

Job description

Analytical Development Lead — Senior Director / Director

Location:

Seattle, WA (hybrid) — periodic domestic and international travel required to CDMO and contract research laboratory sites

About the Company

We’re 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 execution, and collaborates closely across science and operations to inform decision-making.

The Opportunity

This is a foundational leadership hire who will define and own the analytical strategy and analytical control strategy for our monoclonal antibody pipeline. You’ll provide direct technical oversight of our CDMO and contract research partners across assay development and qualification, drug substance and drug product release and stability plans, and drug substance control strategy, while serving as the analytical voice in our IND and health authority interactions and building the analytical foundation needed for future tech transfer and late-stage development.

Key Responsibilities

Analytical Strategy & Leadership

• Define and own the phase-appropriate analytical strategy and control strategy across the pipeline, from Phase 1 through late-stage development and commercialization
• Lead product characterization and critical quality attribute (CQA) assessment, linking product quality attributes to safety, efficacy, and the target product profile
• Develop and manage the analytical budget and resource plan
• Serve as a key member of the CMC team, contributing to overall CMC strategy, program planning, and risk management

CDMO Analytical Oversight & Assay Development

• Serve as the primary analytical technical point of contact and owner of the analytical control strategy for CDMO and contract testing partner(s) supporting drug substance and drug product development and Phase 1 GMP manufacturing
• Provide scientific and technical oversight of analytical method development, optimization, and phase-appropriate qualification for identity, purity, potency, product‑related variants, and safety attributes (e.g., SEC, CE‑SDS, icIEF/CEX, peptide mapping, glycan analysis, binding and cell‑based potency assays, HCP, residual DNA)
• Review and approve CDMO‑generated method development reports, qualification protocols and reports, and method transfer documentation
• Establish and manage the reference standard strategy, including qualification and ongoing monitoring of reference standards
• Track CDMO and testing lab timelines, budgets, and deliverables; identify and elevate technical or schedule risks and drive them to resolution

Specifications, Release & In-Process Testing

• Establish phase‑appropriate drug substance and drug product release specifications and acceptance criteria, with justifications grounded in development data, batch history, and regulatory expectations
• Review and approve release testing protocols, stability protocols, and certificates of analysis; review and approve release and stability data to support batch disposition
• Review batch records and in‑process testing data in partnership with the process development and quality teams, ensuring in‑process controls, methods, and limits are appropriate and results support batch release
• Lead or oversee investigations of OOS/OOT results and analytical deviations, and review related change controls and CAPAs

Regulatory & Documentation

• Author and review analytical sections of IND filings, including control of drug substance and drug product, analytical procedures and qualification, specifications and justifications, reference standards, and stability
• Lead preparation of responses to FDA and other health authority questions related to analytical methods, specifications, and stability
• Represent the analytical function in health authority interactions, including pre‑IND, Type B/C, and other regulatory meetings, and contribute to global regulatory strategy for multi‑region clinical development
• Ensure CDMO‑and lab‑generated analytical documentation meets GMP, data integrity, and regulatory expectations

Tech Transfer & Late‑Stage Readiness

• Plan and lead future analytical method transfers to new testing laboratories and/or a Phase 3–capable manufacturing site
• Build the analytical knowledge base and method lifecycle plan needed to progress toward method validation, product comparability assessments, and late‑stage commercial specifications
• Develop the long‑term analytical roadmap supporting process changes, site transfers, and commercial readiness, including comparability and stability strategies for BLA
• Operate with a high degree of autonomy, reporting to senior leadership; communicate analytical data, risks, and recommendations clearly to cross‑functional stakeholders, executive leadership, and the Board as needed
• Support business development, partnering, and investor due diligence by representing the analytical and product quality package to external parties
• Collaborate closely with process development, formulation, quality, nonclinical, and regulatory teams to align analytical strategy with overall program timelines
• Coordinate across multiple CDMOs and contract research laboratories to ensure consistent analytical strategy and quality standards

Qualifications

• Ph.D. in analytical chemistry, biochemistry, biotechnology, or a related field with 12+ years of relevant biopharmaceutical industry experience preferred
• Substantial industry experience in analytical development and/or quality control for monoclonal antibodies or other therapeutic proteins
• Hands‑on expertise with biologics characterization and release methods, including chromatographic, electrophoretic, mass spectrometry–based, and bioassay/potency methods
• Direct experience managing CDMO or contract research laboratory relationships for method development, qualification, transfer, and GMP release and stability testing
• Demonstrated experience setting drug substance and drug product specifications and reviewing GMP batch records, release, and stability data
• Experience authoring or reviewing analytical CMC sections of IND filings and contributing to health authority responses
• Solid understanding of GMP, data integrity, and relevant ICH guidelines
• Track record of leading analytical strategy for a biologics program through IND, with drug substance experience strongly preferred
• Demonstrated experience leading direct interactions with FDA and/or other health authorities (e.g., EMA, NMPA)
• Proven people leadership experience, including building, managing, and developing analytical teams

Traits for success

• Strategic thinker who can set analytical direction while remaining hands‑on with data review and day‑to‑day execution in a lean startup environment
• Highly self‑directed with strong scientific judgment and comfort operating independently in ambiguous, fast‑moving environments
• Rigorous, data‑driven problem solver who can quickly assess analytical results and make sound, phase‑appropriate decisions
• Clear communicator who can translate complex analytical and CMC issues for senior leadership and cross‑functional partners
• Detail‑oriented with strong documentation discipline and a quality‑first mindset
• Credible, influential leader who builds trust with internal teams, external partners, regulators, and investors

Why Join Us

• Play a foundational role in a venture‑backed startup, directly shaping our analytical and CMC strategy and building the analytical function from the ground up
• Work closely with seasoned company builders and scientific leadership across the Frazier Life Sciences network
• Own a high‑visibility, high‑impact function during a formative stage of the company