Job Description

Position Summary
The Senior Project Manager is responsible for the on-time delivery of a high-quality in vitro diagnostic (IVD) immunoassay device for neurological biomarkers of Alzheimer’s disease, supporting U.S. and international market launches. This role provides end-to-end project leadership across development, design transfer, manufacturing readiness, regulatory submission, and launch.

Essential Job Functions:

• Lead cross-functional project execution to meet defined scope, schedule, and quality objectives for IVD product development and launch.
• Develop, maintain, and actively manage integrated project plans, milestones, dependencies, and critical paths.
• Proactively lead and coordinate cross-functional teams and subject matter experts from Process Engineering/Product Development, Analytical R&D, Clinical Affairs, Regulatory Affairs, Quality, Manufacturing, Operations Planning, Logistics, and external partners as required.
• Drive Design Transfer into existing manufacturing systems and business processes; identify gaps and lead cross-functional resolution to ensure seamless transition to production.
• Own and maintain core project management artifacts, including risk registers, change management plans, RACI matrices, and stakeholder communication plans.
• Serve as primary interface to Design Review Boards, internal and external steering committees, and key stakeholders.
• Identify, assess, and escalate project risks and issues, lead mitigation planning and decision-making.

Job Specifications (skills, knowledge, special training, certification, license requirements):

• Strong organizational and leadership skills and a positive work-related attitude

• Possesses project management knowledge, work experience and the ability to serve as a champion for the implementation and practice of project management processes and techniques across the organization

• Ability to handle multiple, complex projects simultaneously

• Product/Process development/improvement experience

• Strong communication and interpersonal skills with both technical and non-technical personnel

• Thorough understanding of testing and characterization of immunoassays as defined in CLSI protocols

• Manufacturing, technical transfer and process scale-up skills highly desirable

• Instrumentation (e.g., HPLC, FPLC, spectrophotometer) skills highly desirable

• Experience with automated immunoassay analyzers desirable

• Strong protein modification/chemistry knowledge desirable

• Ability to write clear, concise technical reports and attention to detail is essential

• Must be detail-oriented and thorough

• Ability to work with various statistical and project management software packages

• Ability to make presentations to various groups of individuals

• Ability to supervise personnel

• Ability to work with potentially hazardous materials

• Manual dexterity and ability to do visual inspections

• Excellent attendance required and the ability to work overtime, if needed

Education and Work Experience Required:

• Bachelor’s degree in engineering, life sciences, or related field (Master’s preferred).
• 10+ years of experience in IVD or medical device development, with hands-on leadership of complex, cross-functional projects.
• Strong working knowledge of immunoassay development from concept through design controls, risk management, manufacturing transfer (primary manufacturing and finishing), clinical studies, regulatory submissions, and commercialization.
• Demonstrated experience working within regulated environments, including 21 CFR, ISO 13485, ISO 14971, and MDSAP.
• Proven track record managing external development or manufacturing partners.
• PMP certification preferred.
• Ability to travel domestically and internationally (~10%) as required.

The base salary range for this position is $140,000- $160,000/year. The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

We offer a competitive benefits package that starts on day one, including medical, employer-paid dental & vision, 401(k) match up to 6%, and generous PTO and holiday benefits. The typical work schedule consists of half-day Fridays.

We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer