Program Coordinator, Product Development - Job Opportunity at Fujirebio

Malvern, United States
Full-time
Senior
Posted: February 24, 2025
On-site
USD 90,000 - 120,000 per year based on location, seniority, and specialized diagnostic industry experience

Benefits

Comprehensive dental and vision coverage starting on day one, demonstrating strong employee care
Competitive 401(k) matching up to 5%, above industry average for biotech
Generous PTO and holiday benefits package indicating work-life balance focus
Immediate benefits eligibility showing commitment to employee wellbeing

Key Responsibilities

Strategic coordination of product development initiatives for immunoassay platforms with direct impact on company's diagnostic portfolio
Cross-functional leadership in managing relationships between Product Development, Clinical Affairs, and Manufacturing teams
Technology transfer oversight ensuring successful transition from development to production
Timeline and resource management for complex development projects
Stakeholder alignment and communication across technical and business units

Requirements

Education

B.S. / M.S. in Biological Sciences/Engineering

Experience

5-10 years of laboratory experience, 3 years project management experience

Required Skills

Project Management expertise Leadership skills Strong communication and interpersonal skills Personnel supervision ability Immunoassay development knowledge Manufacturing and Quality Control experience Technical writing ability Detail orientation Organizational skills Software proficiency Presentation skills Project management software mastery
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Sauge AI Market Intelligence

Industry Trends

The diagnostics industry is experiencing rapid growth due to increased demand for automated immunoassay platforms, particularly in response to emerging infectious diseases and personalized medicine requirements. Integration of AI and machine learning in diagnostic development is creating new opportunities for innovative assay development processes. Regulatory requirements in the diagnostics sector are becoming more stringent, particularly for automated platforms, increasing the importance of robust development and validation processes.

Role Significance

Typically operates within a matrix structure overseeing 3-5 concurrent projects with 5-10 team members per project
Senior individual contributor role with significant cross-functional influence and project ownership

Key Projects

New immunoassay platform development initiatives spanning 12-24 months Manufacturing transfer projects requiring extensive stakeholder management Automation and efficiency improvement programs Regulatory compliance and validation projects

Success Factors

Deep understanding of both technical and business aspects of diagnostic development Ability to navigate complex stakeholder environments while maintaining project momentum Strong risk management and problem-solving capabilities in a regulated environment Excellent documentation and process management skills

Market Demand

High demand position due to expanding diagnostic market and increasing automation in laboratory testing. The role combines technical expertise with project management, making it particularly valuable in the current market.

Important Skills

Critical Skills

Project management expertise is essential for coordinating complex development timelines and stakeholder requirements Technical background in immunoassays provides necessary context for effective decision-making Regulatory knowledge ensures compliance throughout development process

Beneficial Skills

Experience with automation systems adds value to platform development projects Quality management system knowledge supports manufacturing transfer activities Business acumen helps in strategic project prioritization

Unique Aspects

Rare combination of technical development and program management responsibilities
Direct involvement in cutting-edge immunoassay development
Opportunity to influence future diagnostic platforms

Career Growth

2-4 years in role typically required before advancement to director-level positions

Potential Next Roles

Product Development Director Program Management Office (PMO) Director Technical Operations Manager R&D Project Portfolio Manager

Company Overview

Fujirebio

Fujirebio is a leading global diagnostics company specializing in high-quality in vitro diagnostics solutions

Well-established player in the diagnostic market with strong presence in automated immunoassay systems
Strategic location in Malvern biotech corridor with significant R&D operations
Professional environment with emphasis on technical excellence and regulatory compliance
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