Bio-Techne in San Jose, CA seeks a Senior Project Manager to lead complex NPI, sustaining engineering, and strategic initiatives for Simple Western and Biologics products. You will collaborate with R&D, Systems, Mechanical, Software, Manufacturing, Quality, Regulatory, and Commercial teams to deliver instruments, consumables, reagents, and software from concept to launch and lifecycle management. A strong program leadership background and experience in regulated settings are required.
Qualifications
Bachelor's degree in mechanical, biomedical, systems or related disciplines; 8+ years in life sciences/biotech/medical devices
Experience leading multiple concurrent NPI programs and cross-functional teams through full product lifecycle
Experience with regulated environments (ISO 9001/13485, GMP) and presenting to senior leadership
Responsibilities
Lead complex NPI, sustaining engineering, and strategic initiatives across ASD portfolio focusing on Simple Western and Biologics.
Drive cross-functional teams through product development, verification, validation, manufacturing transfer, launch and post-launch activities.
Develop integrated project plans, critical paths, and resource forecasts across hardware, software, consumables, and manufacturing workstreams.
Identify and mitigate technical, schedule, supply chain, quality, and commercialization risks.
Facilitate phase-gate reviews and governance with Engineering, Product Management, Supply Chain, and Regulatory teams.
Skills
Cross-functional leadership
NPI program management
Regulatory experience
Data analytics
Education
Bachelor's in Mechanical Engineering
Life sciences instrumentation experience
Tools
Power BI
Jira
Smartsheet
Job description
Bio-Techne in San Jose, CA seeks a Senior Project Manager to lead complex NPI, sustaining engineering, and strategic initiatives for Simple Western and Biologics products. You will collaborate with R&D, Systems, Mechanical, Software, Manufacturing, Quality, Regulatory, and Commercial teams to deliver instruments, consumables, reagents, and software from concept to launch and lifecycle management. A strong program leadership background and experience in regulated settings are required.