Project Manager/Sr. Project Manager

Job Summary:
We are seeking a skilled and versatile technical Project Manager to lead cross-functional teams in the execution of customer projects, customer production demand, and internal infrastructure initiatives. The ideal candidate will have a strong background in project management within the life sciences and/or diagnostics sector, with proven experience driving projects from concept through completion in a regulated environment. This role will collaborate with R&D, Manufacturing, Quality, IT, and external partners to ensure projects are delivered on time, within scope, and in compliance with quality and regulatory standards.

Key Responsibilities:

• Lead planning, execution, and delivery of Life-Sciences based development projects, customer project schedules, and internal infrastructure improvements
• Develop and drive detailed project plans, timelines, budgets, and resource allocations; monitor progress against milestones and adjust as needed
• Coordinate cross-functional teams, including customers, R&D, Manufacturing, Quality, and contractors in order to achieve project objectives
• Manage stakeholder communications, including regular status updates, risk assessments, action tracking, and issue resolution
• Advocate for customer project and product demand
• Facilitate project meetings, workshops, customer progress reviews, and internal progress reviews
• Working closely with stakeholders, ensure compliance with customer requirements, regulatory requirements, and company quality systems
• Identify, assess, and mitigate project risks; drive implementation of corrective actions as needed
• Oversee project documentation, including requirements, protocols, validation plans, and technical reports
• Support change management and training initiatives for new processes and systems
• Drive continuous improvement in project management practices and operational efficiency

Required Skills & Qualifications:

• Bachelors degree or advanced degree in life sciences, engineering, business, or related field
• 3+ years of project management experience in biotech, diagnostics, pharmaceutical, or medical device industry
• Project Management Professional (PMP) certification or equivalent preferred
• Experience managing projects in a regulated environment (e.g., ISO13485, FDA)
• Strong knowledge of formulation, filling, assembly, final kitting, and distribution in a consumables based manufacturing environment
• Strong knowledge of project management methodologies (Agile, Waterfall, etc.) and tools (e.g., MS Project, Smartsheet)
• Excellent problem-solving, analytical, and organizational skills
• Proven ability to communicate effectively with technical and non-technical stakeholders at all levels
• Demonstrated leadership in cross-functional team environments
• Experience with resource management, budget tracking, and issue resolution
• High level of computer proficiency; experience with data analysis and reporting tools is a plus

Equal Opportunity Employer
We are an equal opportunity employer and value diversity at our company. We are committed to providing equal employment opportunities without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or any other protected characteristic as established by law.