Process Development Lead
Work In Biotech · Seattle, Washington, United States
FULL TIMEpermanent
Job Description
Process Development Lead — Senior Scientist / DirectorLocation: Seattle, WA (hybrid) — significant domestic and international travel required, including extended on-site stays at CDMO manufacturing facilitiesCompany: 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 CompanyWe’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 OpportunityThis 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 ManufacturingServe 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 manufacturingProvide scientific and technical oversight of clone selection, cell banking (MCB/WCB), process optimization, scale-up, and technology transfer activities conducted at CDMO sitesServe 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 oversightReview and approve CDMO-generated batch records, deviations, change controls, technology transfer protocols, and technical reportsTrack CDMO timelines, budgets, and deliverables; identify and escalate technical or schedule risks and drive them to resolution
Regulatory & DocumentationReview CMC sections of IND filings, including process descriptions, manufacturing summaries, and comparability assessmentsEnsure CDMO-generated documentation (batch records, protocols, reports) meets GMP and regulatory expectationsSupport responses to health authority questions related to process development and manufacturing
Tech Transfer & Phase 3 ReadinessLead planning for future technology transfer activities to support scale-up and/or transition to a Phase 3–capable manufacturing siteBuild the process knowledge, documentation, and institutional understanding needed for a smooth transition from Phase 1 to late-stage manufacturing
Collaboration & CommunicationOperate independently with strategic oversight from senior leadership; communicate technical updates, risks, and recommendations clearly to cross-functional stakeholders and leadershipCollaborate closely with preclinical, quality, and regulatory teams to align process development with overall program timelinesCoordinate across multiple CDMOs and external partners to ensure consistent technical strategy and quality standards
QualificationsBachelor’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 developmentDirect experience managing CDMO relationships for cell line development, process development, and/or GMP manufacturingExperience serving as person-in-plant or providing hands-on technical oversight during GMP manufacturing campaignsWorking knowledge of IND-enabling CMC requirements, xzbcwsv with experience contributing to or reviewing IND documentationWillingness and ability to travel internationally, including extended on-site stays during GMP manufacturing campaignsSolid understanding of GMP, quality systems, and regulatory expectations for biologics manufacturing
Traits for successHighly self-directed with strong technical judgment and comfort operating independently in ambiguous, fast-moving environmentsConfident on-the-ground problem solver, comfortable serving as the technical decision-maker during time-sensitive manufacturing campaignsClear communicator who can translate complex technical and CMC issues for senior leadership and cross-functional partnersDetail-oriented with strong documentation discipline and a quality-first mindset
Title & LevelLevel open: we anticipate hiring between Senior Scientist and Director, commensurate with experience.
Why Join UsPlay a foundational role in a venture-backed startup, directly shaping our CMC and manufacturing strategyWork closely with seasoned company builders and scientific leadership across the Frazier Life Sciences networkOwn a high-visibility, high-impact function during a formative stage of the company
Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap.
About the CompanyWe’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 OpportunityThis 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 ManufacturingServe 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 manufacturingProvide scientific and technical oversight of clone selection, cell banking (MCB/WCB), process optimization, scale-up, and technology transfer activities conducted at CDMO sitesServe 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 oversightReview and approve CDMO-generated batch records, deviations, change controls, technology transfer protocols, and technical reportsTrack CDMO timelines, budgets, and deliverables; identify and escalate technical or schedule risks and drive them to resolution
Regulatory & DocumentationReview CMC sections of IND filings, including process descriptions, manufacturing summaries, and comparability assessmentsEnsure CDMO-generated documentation (batch records, protocols, reports) meets GMP and regulatory expectationsSupport responses to health authority questions related to process development and manufacturing
Tech Transfer & Phase 3 ReadinessLead planning for future technology transfer activities to support scale-up and/or transition to a Phase 3–capable manufacturing siteBuild the process knowledge, documentation, and institutional understanding needed for a smooth transition from Phase 1 to late-stage manufacturing
Collaboration & CommunicationOperate independently with strategic oversight from senior leadership; communicate technical updates, risks, and recommendations clearly to cross-functional stakeholders and leadershipCollaborate closely with preclinical, quality, and regulatory teams to align process development with overall program timelinesCoordinate across multiple CDMOs and external partners to ensure consistent technical strategy and quality standards
QualificationsBachelor’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 developmentDirect experience managing CDMO relationships for cell line development, process development, and/or GMP manufacturingExperience serving as person-in-plant or providing hands-on technical oversight during GMP manufacturing campaignsWorking knowledge of IND-enabling CMC requirements, xzbcwsv with experience contributing to or reviewing IND documentationWillingness and ability to travel internationally, including extended on-site stays during GMP manufacturing campaignsSolid understanding of GMP, quality systems, and regulatory expectations for biologics manufacturing
Traits for successHighly self-directed with strong technical judgment and comfort operating independently in ambiguous, fast-moving environmentsConfident on-the-ground problem solver, comfortable serving as the technical decision-maker during time-sensitive manufacturing campaignsClear communicator who can translate complex technical and CMC issues for senior leadership and cross-functional partnersDetail-oriented with strong documentation discipline and a quality-first mindset
Title & LevelLevel open: we anticipate hiring between Senior Scientist and Director, commensurate with experience.
Why Join UsPlay a foundational role in a venture-backed startup, directly shaping our CMC and manufacturing strategyWork closely with seasoned company builders and scientific leadership across the Frazier Life Sciences networkOwn a high-visibility, high-impact function during a formative stage of the company
Details
| Company | Work In Biotech |
| Location | Seattle, Washington, United States |
| Type | FULL TIME |
| Niche | general |
| Experience | permanent |