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InBios International, Inc. · 2 weeks ago

Scientific Project Manager (In Vitro Diagnostics)

Seattle, WA

Full-time

Onsite

Mid, Senior Level

$88K/yr - $125K/yr

InBios International, Inc. is a mission-focused biotech company developing diagnostic tools that combat infectious diseases worldwide. The Scientific Project Manager will lead in vitro diagnostic development programs, managing government-funded projects from early development through regulatory submission.

Biotechnology

Responsibilities

Lead end-to-end project management for IVD programs, from proposal development through regulatory clearance

Manage government-funded contracts and grants, ensuring compliance with technical, financial, and reporting requirements

Develop and maintain project timelines, budgets, resources, and risk mitigation plans

Coordinate assay development and validation across immunochemistry platforms (e.g., lateral flow, ELISA) and molecular diagnostics (e.g., PCR, nucleic acid–based methods)

Support cGMP manufacturing, technology transfer, and validation activities

Support FDA and CE/IVDR regulatory submissions in collaboration with regulatory and quality teams

Serve as primary liaison with internal teams, CROs, clinical sites, academic collaborators, and government agencies

Oversee preparation of project documentation, protocols, reports, and sponsor communications

Qualification

Diagnostic DevelopmentProject ManagementImmunochemistry KnowledgeMolecular Diagnostics KnowledgeCGMP ExperienceFDA Regulatory KnowledgeAnalytical SkillsProject Management ToolsCommunication SkillsOrganizational Skills

Required

MS or PhD in relevant life science, or equivalent experience

Demonstrated experience managing diagnostic development programs in infectious diseases and/or oncology

Proven experience managing federally funded research or product development programs

Working knowledge of immunochemistry-based and molecular diagnostic assay development

Experience in cGMP-regulated environments

Familiarity with FDA regulatory pathways; CE/IVDR experience preferred

Strong organizational, analytical, and communication skills

Preferred

Proficiency with project management tools (e.g., Microsoft Project)

Experience supporting FDA submissions and/or CE marking for IVDs

Benefits

Medical, dental, vision, life & disability insurance

401(k) + Roth IRA + FSA

2 weeks paid vacation + 11 paid holidays , which includes the annual “winter-break” week (Christmas Day through New Year’s Day).

Supportive, mission-driven culture

Company

InBios International, Inc.

InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats.

Founded in 1996