About this opportunity
Work In Biotech lists this Process Development Lead opportunity in seattle, Washington. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap.
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, xhqgsiq 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
Worksite address
seattle, WA, 98127, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.