Process Development Lead

Process Development Lead — Senior Scientist / Director

Location: Seattle, WA (hybrid) — significant domestic and international travel required, including extended on-site stays at CDMO manufacturing facilities

Company: Stealth-mode biotech

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 hire who will own CMC process development and manufacturing execution for our lead monoclonal antibody program. You’ll provide direct technical oversight of our CDMO partner(s) across cell line development, upstream/downstream process development, and Phase 1 GMP manufacturing — serving as our person-in-plant during manufacturing campaigns — while building the process knowledge and documentation base needed for tech transfer and Phase 3 readiness.

Key Responsibilities

CDMO Oversight & GMP Manufacturing

• Serve as the primary technical point of contact and process owner for CDMO partner(s) executing cell line development, upstream/downstream process development, and Phase 1 GMP drug substance and drug product manufacturing
• Provide scientific and technical oversight of clone selection, cell banking (MCB/WCB), process optimization, scale-up, and technology transfer activities conducted at CDMO sites
• Serve as person-in-plant during GMP manufacturing campaigns, including international travel to CDMO facilities, to provide real-time technical decision-making, troubleshooting, and in-process quality oversight
• Review and approve CDMO-generated batch records, deviations, change controls, technology transfer protocols, and technical reports
• Track CDMO timelines, budgets, and deliverables; identify and escalate technical or schedule risks and drive them to resolution

Regulatory & Documentation

• Review CMC sections of IND filings, including process descriptions, manufacturing summaries, and comparability assessments
• Ensure CDMO-generated documentation (batch records, protocols, reports) meets GMP and regulatory expectations
• Support responses to health authority questions related to process development and manufacturing

Tech Transfer & Phase 3 Readiness

• Lead planning for future technology transfer activities to support scale-up and/or transition to a Phase 3–capable manufacturing site
• Build the process knowledge, documentation, and institutional understanding needed for a smooth transition from Phase 1 to late-stage manufacturing

Collaboration & Communication

• Operate independently with strategic oversight from senior leadership; communicate technical updates, risks, and recommendations clearly to cross-functional stakeholders and leadership
• Collaborate closely with preclinical, quality, and regulatory teams to align process development with overall program timelines
• Coordinate across multiple CDMOs and external partners to ensure consistent technical strategy and quality standards

Qualifications

• Bachelor’s, Master’s, or Ph.D. in biochemistry, chemical engineering, biotechnology, or a related field; required degree level and years of industry experience scale with seniority (Senior Scientist through Director)
• Substantial industry experience in monoclonal antibody process development (upstream and/or downstream), including direct involvement in or oversight of cell line development
• Direct experience managing CDMO relationships for cell line development, process development, and/or GMP manufacturing
• Experience serving as person-in-plant or providing hands-on technical oversight during GMP manufacturing campaigns
• Working knowledge of IND-enabling CMC requirements, with experience contributing to or reviewing IND documentation
• Willingness and ability to travel internationally, including extended on-site stays during GMP manufacturing campaigns
• Solid understanding of GMP, quality systems, and regulatory expectations for biologics manufacturing

Traits for success

• Highly self-directed with strong technical judgment and comfort operating independently in ambiguous, fast-moving environments
• Confident on-the-ground problem solver, comfortable serving as the technical decision-maker during time-sensitive manufacturing campaigns
• Clear communicator who can translate complex technical and CMC issues for senior leadership and cross-functional partners
• Detail-oriented with strong documentation discipline and a quality-first mindset

Title & Level

Level open: we anticipate hiring between Senior Scientist and Director, commensurate with experience.

Why Join Us

• Play a foundational role in a venture-backed startup, directly shaping our CMC and manufacturing strategy
• 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