Hybrid IVD Program Manager: Regulatory & Clinical

INBIOS INTERNATIONAL INC; Washington (District of Columbia); Vor Ort; USD 88.000 - 125.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision, life &dis

401(k) + Roth IRA + FSA

2 weeks paid vacation

11 paid holidays

Mission-driven culture

Zusammenfassung

INBIOS INTERNATIONAL INC in Seattle is seeking a Scientific Project Manager to lead in vitro diagnostic (IVD) development programs in infectious diseases and oncology. You will manage government-funded contracts from proposal through regulatory clearance, collaborating with regulatory and quality teams to prepare FDA and CE submissions.

The role demands strong project leadership across immunochemistry and molecular diagnostics, cGMP manufacturing support, and coordination with internal teams,

Qualifikationen

• MS or PhD in relevant life science, or equivalent experience.
• Experience managing diagnostic development programs in infectious diseases and/or oncology.
• 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.

Aufgaben

• 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 and molecular diagnostics.
• 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.

Kenntnisse

Project management

Analytical skills

Communication skills

Ausbildung

MS/PhD in life science

Tools

Microsoft Project

Jobbeschreibung

INBIOS INTERNATIONAL INC in Seattle is seeking a Scientific Project Manager to lead in vitro diagnostic (IVD) development programs in infectious diseases and oncology. You will manage government-funded contracts from proposal through regulatory clearance, collaborating with regulatory and quality teams to prepare FDA and CE submissions.

The role demands strong project leadership across immunochemistry and molecular diagnostics, cGMP manufacturing support, and coordination with internal teams,