Project Manager

Job Description/Summary:

Perform the full project-management function for cross-functional projects involving custom assay development, software, equipment, manufacturing, and related product-development activities. Manage plans, budgets, timelines, customer communications, project decisions, and Design History File documentation from initial evaluation through transfer and commercialization. Work independently within approved plans, seeking guidance or escalating decisions when project complexity, risk, or business impact warrants additional review.

Responsibilities:

• Develop and maintain project plans, timelines, budgets, priorities, and risk assessments using appropriate waterfall, agile, or hybrid methods.
• Manage assigned customer and internal development projects through the full product development cycle.
• Coordinate cross-functional tasks, dependencies, deliverables, and action items.
• Track progress and escalate risks, delays, resource constraints, or scope changes promptly.
• Ensure project requirements documented in Statements of Work, design inputs, and other approved requirements are addressed and verified.
• Maintain complete, accurate, and current Design History Files in accordance with the QMS and applicable ISO 9001:2015 Clause 8.3 and ISO 13485:2016 Clause 7.3 requirements.
• Coordinate risk-management and change-control activities.
• Confirm current approved templates are used and records are uploaded to the appropriate controlled location.
• Serve as the primary day-to-day customer contact for assigned projects.
• Communicate progress, timeline expectations, changes, risks, and data or product deliverables.
• Establish an appropriate meeting cadence and document decisions and action items.
• Track project budgets, costs, resources, invoicing, and billing; provide reports at project close and as requested.
• Coordinate the transfer of materials, documentation, methods, and information from R&D to Production.
• Confirm materials and locations are documented and relevant personnel can access approved SOPs and master records.
• Coordinate meetings, prepare and distribute minutes, and follow up on action items, including project updates, exit reviews, transfer meetings, and customer meetings.
• Support supply and resource planning, including sourcing activities, supplier coordination, and identification of supply-chain risks.
• Research and coordinate applicable quality and regulatory requirements for new products or markets in collaboration with Quality and Regulatory personnel.
• Support continuous improvement of project-management templates, reporting practices, risk controls, and lessons-learned processes.
• Confirm projects remain aligned with approved customer requirements, marketing plans, annual budgets, quality objectives, and company strategy; escalate misalignment for decision.

Experience and Qualifications:

• Bachelor's degree in biology, chemistry, biotechnology, life sciences, business, engineering, or a related field; equivalent relevant education and experience may be considered.
• Typically 1-3 years of project coordination or project management experience; experience in a regulated research, clinical, biotechnology, medical-device, or life-science setting preferred.
• Project management certification or completion of a recognized project management curriculum preferred.
• Experience with ISO 9001, ISO 13485, 21 CFR Part 820, an integrated quality management system, or cGMP preferred.

Required Skills:

• Strong written, verbal, meeting-facilitation, and presentation skills.
• Ability to communicate technical information to technical and non-technical audiences and maintain productive customer relationships.
• Ability to organize multiple priorities, maintain accurate records, follow through on commitments, and work effectively across departments.
• Working knowledge of project scheduling, budget tracking, risk management, change control, and design-control documentation.
• Proficiency with Microsoft Office and project-management tools; advanced Excel skills, including macros, are a plus.
• Ability to interpret requirements and instructions presented in written, oral, diagram, or schedule form and to respond professionally to customer or regulatory inquiries.