Location: Eden Prairie, MN
Position: Contractor – Senior Project Manager
Hourly Rate: $100.00–$125.00 per hour
Work Arrangement: 100% onsite in Eden Prairie - Monday through Friday, 7am to 4pm
Contract Length: 6 months, with the potential to convert to a full-time position in the future
Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.
Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM ;
RESPONSIBILITIES
- Champion and drive execution of CDMO Project Management activities including: milestones, schedules, budgets, resources, status reports, and internal & external communication
- Prepare project plans, timelines, and budgets
- Actively manage project timelines and budgets from initiation through completion, ensuring projects are delivered on time and within budget
- Ensure key stakeholders are informed of project status
- Manage resource allocation for CDMO projects
- Actively manage and mitigate project risks and issues
- Track and communicate KPIs
- Partner closely with commercial team to assess and to develop client proposals and quotations
- Ability to quickly assess active projects, establish current status, identify risks, and assume ownership with minimal disruption.
- Build and maintain strong long-term relationships with clients. Demonstrate effective communication and interactions with clients, lead tactful and strategic conversations, understand client needs and expectations, and navigate issue resolution.
- Actively engage and collaborate on global cross functional product development teams
- Medical Device Design Control and Risk Management
- Prepare documentation in accordance with relevant internal SOPs
- Author engineering reports and presentations as required to document and communicate results.
- Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as appropriate.
- Support sustaining and process engineering efforts during process scale-up and manufacturing improvement initiatives
- Lead and coordinate design transfer activities to ensure product designs, specifications, manufacturing documentation, and process requirements are effectively transitioned into controlled manufacturing operations.
- Oversee pre-validation manufacturing activities by managing workload, priorities, and cross-functional execution to support development builds, readiness activities, and progression toward validation
- Other duties as assigned
REQUIREMENTS
Education
- Bachelor’s degree in Material Science, Bioengineering, chemistry or engineering related field
Experience
- 5+ years of project management/technical team leadership experience
Certification
- PMP certification, preferred
Skills
- Excellent verbal and written communication
- Microsoft Office Suite
- Proven ability to operate in a matrix organization and work effectively with leadership, clients, and across geographic and organization boundaries.
- Strong time management and prioritization skills are required for management of multiple projects; Adaptability to rapidly changing priorities.
- Thorough understanding of medical device industry.
Travel
N/A
SAFETY
Physical Requirement
- Move or lift objects up to 25 pounds
- Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
- Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
Working Environment
Onsite: Office environment with assigned workstation
More about Evergen:
Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.
Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:
- Accountable: We own our actions and decisions.
- Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
- Growth Mindset: We embrace challenges as opportunities for continuous learning.
- Customer-Centric: We prioritize customers at every touch point.
- Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired Evergen in 2020 and has supported the transformation of the company to its next level of potential.
#LI-Onsite
Skills Required
- Bachelor's degree in Material Science, Bioengineering, Chemistry, or an engineering-related field
- 5+ years of project management or technical team leadership experience
- Excellent verbal and written communication skills
- Microsoft Office Suite proficiency
- Ability to operate effectively in a matrix organization and collaborate across leadership, clients, geographic regions, and organizational boundaries
- Strong time management, prioritization, and adaptability while managing multiple projects and changing priorities
- Thorough understanding of the medical device industry
- PMP certification
What We Do
Evergen is a leading Contract Development and Manufacturing Organization (CDMO) pushing the boundaries of innovation and tissue engineering to meet patient needs in regenerative medicine. We are expert partners to Original Equipment Manufacturers (OEMs), working with them to identify clinical problems and develop customized solutions that promote healing, accelerate recovery, and help prevent complications. Using our extensive portfolio of biological materials, we focus on specialized clinical segments, including plastic and reconstructive surgery, sports medicine and orthopedics, cardiac, and neurosurgery. Our Mission is to enhance patients' lives by creating the best clinical outcomes through innovative, high-quality medical solutions.
