Process Development Leader: GMP/CDMO Oversight

Work In Biotech; Seattle (WA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Work In Biotech is seeking a Process Development Lead — Senior Scientist / Director in Seattle, hybrid, to own CMC process development and manage CDMO partnerships.

You will oversee monoclonal antibody upstream/downstream development, scale-up, tech transfer, and GMP manufacturing campaigns, with international travel.

This foundational role reports to senior leadership and partners with regulatory, QA, and preclinical teams to ensure Phase 1 readiness and Phase 3 transition.

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

Responsibilities

• Serve as the primary technical point of contact and process owner for CDMO partners 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
• 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
• 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
• 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

Skills

Technical leadership

GMP manufacturing oversight

Cell line development

Process development

Documentation & QA

Education

Biochemistry / Chemical Engineering / Biotechnology (advanced degree)

Job description

Work In Biotech is seeking a Process Development Lead — Senior Scientist / Director in Seattle, hybrid, to own CMC process development and manage CDMO partnerships.

You will oversee monoclonal antibody upstream/downstream development, scale-up, tech transfer, and GMP manufacturing campaigns, with international travel.

This foundational role reports to senior leadership and partners with regulatory, QA, and preclinical teams to ensure Phase 1 readiness and Phase 3 transition.