Technology Transfer Project Manager I

Position Summary

Implements and administers multiple projects of low to medium complexity, each potentially consisting of sub-projects. Organizes cross-functional activities to ensure project completion while adhering to regulations, scope, and schedule requirements. Acts as an in-house consultant for project evaluation needs. Plans and directs implementation efforts, evaluating the scope and impact of new products and processes, and providing feedback on proposed changes.

Primary Duties

· Ensures all work complies with company policy and adheres to bioMerieux’s Quality System guidelines.

· Coordinates efforts for the transfer (industrialization) of instrument products and/or manufacturing equipment from R&D to Instrument Manufacturing.

· Lead and monitor projects, applying best practices throughout initiation, planning, development, implementation, and launch. Ensure projects meet quality, scope, and schedule objectives while maintaining regulatory standards and quality system requirements.

· Plan and direct cross-functional change implementation, including evaluating impact, risks, and scope for new and existing products and processes.

· Act as the point of contact and transfer expert for assigned projects. Provide technical support and improvements to existing products and processes.

· Ensure consistent practices are maintained throughout all phases of the project life cycle.

· Schedule meetings, create agendas, and document meeting minutes, correspondence, and presentations.

· Develop, establish, and maintain accurate project timelines.

· Coordinate updates to manufacturing process documents, including Standard Operating Procedures, Batch Records, risk assessments, specification documents, and drawings.

· Communicate, prepare, and present reports, summaries, and analyses to support project status and progress.

· Create and maintain relevant project documentation throughout the project lifecycle.

· Execute high-quality, integrated, cross-functional plans for projects.

· Interact with and coordinate activities between Engineering R&D, Program Management, Supply Chain, Purchasing, Materials Management, Quality Assurance, Software, Service, Manufacturing, and Regulatory departments.

· Perform other duties as assigned.

Supplemental Data

· This position is an individual contributor role with no supervisory responsibilities.

· Occasional travel to vendor locations, both domestically and internationally, may be required.

Training, Education and Experience

· A bachelor’s degree in chemistry, biology, physics, math, engineering, or a closely related field is required. Significant related experience may be considered in lieu of a degree.

· An MBA and/or PMP certification from the Project Management Institute is desired but not required.

· At least three years of relevant work experience.

· Minimum of two years of project management or related experience.

· A Master’s degree or PhD in a related field may substitute for the required project management experience.

Preferred:

· At least three years of experience working in ISO 9001/13485 and/or cGMP/cGLP compliant environments.

Knowledge, Skills and Abilities

Required:

· Ability to work effectively both independently and as part of a team.

· Strong time management skills to efficiently handle multiple projects simultaneously.

· Proficiency in writing detailed reports and procedures.

· Excellent documentation practices, organizational skills, and attention to detail.

· Ability to define problems, collect relevant data, establish facts, and draw valid conclusions.

· Exceptional written and verbal communication skills, along with strong interpersonal abilities.

· Proficiency with MS Office Suite, including Word, Excel, and PowerPoint.

· Strong decision-making abilities.

· Ability to elicit cooperation and coordinate activities across multiple departments.

· Ability to prioritize and execute tasks effectively in a fast-paced environment.

· Strong problem-solving skills.

Preferred:

· Strong statistical and analytical skills.

· Familiarity with project management tools such as Asana and Visio.

Working Conditions and Physical Requirements

· Ability to remain in a stationary position, often standing or sitting, for prolonged periods.

· General physical requirements found in an office setting.

· Minimal Travel 1% of time