Description

Position Summary

We are seeking a precise and hands-on Project Manager who will be responsible for overseeing and executing key projects within our product portfolio. The successful candidate will work cross-functionally with teams in research and development, regulatory affairs, operations, and other departments to ensure projects are delivered on time, within budget, and in accordance with regulatory standards.

Essential Functions

Project Planning & Execution:
• Develop comprehensive project plans, outlining scope, objectives, timelines, resources, and milestones.
• Ensure that all phases of the project life cycle are effectively managed and aligned with company goals.

Cross-functional Coordination:
• Collaborate with internal teams (e.g., R&D, regulatory, manufacturing) and external stakeholders (e.g., vendors, contractors) to ensure project objectives are met and risks are mitigated.

Budget & Resource Management
• Monitor project budgets, ensuring costs are controlled, and identify resource needs to meet timelines.
• Ensure that all necessary resources (personnel, equipment, etc.) are available and properly allocated.

Risk Management & Issue Resolution
• Identify potential risks and bottlenecks in project timelines or processes, developing strategies to address them proactively
• Resolve project-related issues and provide recommendations for adjustments as needed

Regulatory & Compliance
• Ensure all projects are in compliance with relevant regulations and industry standards.
• Work closely with the regulatory affairs team to ensure the timely submission of required documents

Communication
• Act as the primary point of contact for project updates, providing regular status reports to stakeholders and senior leadership.
• Communicate project risks, achievements, and progress clearly and concisely.

Performance Tracking & Reporting
• Track project milestones, deliverables, and timelines using project management tools.
• Provide regular updates and recommendations for improvements.

Continuous Improvement
• Participate in post-project reviews to analyze the outcomes and implement best practices for future projects.

This job description is not intended to be an exhaustive list of all duties, responsibilities, or

qualifications associated with the job. Other duties may be assigned.

Minimum Qualifications

Education:

Bachelor's degree in Engineering, Life Sciences, or a related field required

Experience:
• Minimum of 5-10 years of experience in project management within the biologics or medical device industries
• Experienced in product development under design control

Certifications:
• Certification in Project Management (e.g. PMP, CAPM) is preferred
• Lean Six Sigma Certification is a plus

Knowledge, Skills, and Abilities
• Knowledge of project management methodologies
• Proficiency in project management tools, such as Smart Sheets and/or Microsoft Project
• Experience in managing cross-functional teams and working with both internal and external stakeholders
• Exceptional organizational and time-management skills, with the ability to prioritize tasks and manage multiple projects simultaneously
• Strong problem solving and critical thinking skills
• Stellar communication skills with the ability to interact with stakeholders at all levels

Physical Requirements
• Prolonged periods of sitting and working on a computer, including use of standard office equipment (keyboard, mouse, monitor)
• Ability to communicate effectively, including speaking, hearing, and exchanging information with internal and external stakeholders
• Frequent use of hands and fingers to handle, feel, and operate office equipment and tools
• Occasional standing, walking, and moving between office, laboratory, and manufacturing environments
• Ability to lift and/or move up to 15 pounds occasionally (e.g., files, documents, or light equipment)
• Visual ability to read and analyze data, reports, and project documentation on screens and in print
• May require occasional travel between facilities or to external partner/vendor locations

Work Environment

Employees in this role may be exposed to a variety of environmental, activity-related, and ergonomic hazards throughout the workday. Environmental risks include potential spills, weather-related conditions, inadequate ventilation, exposure to extreme heat or cold, poor housekeeping, chemical exposure, and slip, trip, and fall hazards. Activity-related hazards may involve working around burn or heat sources, compressed gases, electrical cords and tools, energized equipment, and possible exposure to contagious diseases or other unforeseen risks. Ergonomic hazards are also present, including lifting, awkward postures, repetitive motions, and prolonged periods of sitting or standing. Specific job tasks such as sitting at a workstation for extended periods can lead to back, shoulder, hand, arm injuries, and eye strain, while prolonged standing may result in strains, sprains, and leg or knee injuries. Walking throughout the building introduces the risk of slips, trips, falls, and strains, particularly if walkways are obstructed or wet. Additionally, cleaning up spills can pose hazards such as slips, trips, strains, and potential exposure to bloodborne pathogens. Overall, employees must remain aware of these hazards to reduce the risk of injury in the workplace.

Travel Requirements

None

What we offer:Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.