Position Summary:

The Project Manager, CDx and Commercial Project Management will be responsible for directing project management activities related to in vitro diagnostics (IVD)/ companion diagnostic product development programs. The position requires experience running complex projects within the product development environment, a natural aptitude for keeping track of multiple details, and strong planning and communication skills.

Essential functions of the job include but are not limited to:

Design Control Lead for CDx / Product Development:

• Oversee delivery of laboratory services under design control at Precision’s ISO 13485:2016, ISO 15189:2012, CAP/CLIA certified facility
• Design and develop logistical plans, making recommendations to clients on study designs, to ensure all aspects of design control are achieved
• Design, implement, and manage new and existing projects under design control in a manner consistent with Precision For Medicine’s repository mission and management philosophy
• Author or review design control documentation as appropriate such as design requirements, product requirements, manufacturing assessments, design and development plans, FMEAs, risk management plans, raw material documents, and part number documents
• Establish and maintain the Device History File, and all elements therein
• Serve as the laboratory design control lead for the development of companion diagnostics (CDx), spanning feasibility, development, design verification, and design validation through to regulatory clearance or approval
• Provide support for activities related to CDx post-market requirements and commercial sample testing

Communications and Reporting:

• Drive the projects by developing communication and reporting structures and processes for both internal and external clients and collaborators to keep projects on time and on budget
• Assist internal and external clients and collaborators in the design and implementation of studies supporting the product development process through all phases of design control
• Manage cross-functional internal and external project teams by driving meeting management, agendas, minutes, and all key project deliverables
• Prepare reports and correspondences to internal and external clients, collaborators, and department director
• Resolve and assist in resolution of operational issues

Project Management:

• Take accountability for the project plan, designing efficient tools that meet the needs of the program and ensuring that all information is up to date and clear of obsolete documentation
• Manage all tasks in an efficient manner
• Engage with all repository operations through interacting, coordinating, and prioritizing activities
• Coordinate with cross functional team leads on complex projects to ensure all deliverables are tracking to agreed timelines
• Ensure quality control procedures are executed
• Enforce applicable regulations and standards
• Review and approve all documentation associated with project(s)
• Create relevant metrics for business and project measurement
• Ability to respond timely to emergency events
• Perform other duties as assigned

Business Development:

• Evaluate contract/project budgets on a monthly basis and report unexpected variances to department director
• Participate in bidding on new projects, writing proposals, and preparing budgets
• Coordinate the development and implementation of new laboratory projects

Qualifications:

Minimum Required:

• Bachelor’s Degree in Biology or related field
• 3 years’ experience developing products under design control
• 3 years’ experience in Project Management in a scientific or technical discipline managing/leading large/complex projects

Other Required:

• Excellent communication, interpersonal, organizational and multi-tasking skills
• Strong understanding of QSR and ISO regulatory requirements
• Strong understanding and experience with Design Control requirements
• Excellent use of judgment and discretion required
• Proficiency in MS Office (Word, Excel, PowerPoint)
• Highly organized and detail-oriented
• Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities
• Ability to read, write, speak fluently and comprehend the English language

Preferred:

• S. or Ph.D. with minimum of 5 years’ experience developing products under design control
• Minimum of 5 years’ experience in Project Management in a scientific or technical discipline managing/leading large/complex projects
• Experience in developing in vitro diagnostic products under design control
• Experience in writing technical grant or contract proposal responses
• Experience with project management software such as MS Project