Combination Products Project Manager

About the role

Is Kymanox the right fit for you? You want to make a difference and have an impact. You enjoy having an influence in your day-to-day work. You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow. You wake up every day and do what you do because patients deserve better. If this sounds like you, you’ve come to the right place.

The Combination Products Project Manager position provides a wide range of support in the life sciences on a portfolio of 1–5 projects covering a wide range of development, compliance, and commercialization challenges.

Join Kymanox – a life sciences professional services company dedicated to life sciences that has successfully delivered over 4,000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation for providing unparalleled professional services and a highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole. Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management, servicing clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Corporate HQ is based in Research Triangle Park, NC.

The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.

Responsibilities

• Technical Project Leadership
  • Project Oversight: Provide technical project management support, including scheduling, budget oversight, risk management, and resource allocation.
  • Technical Excellence: Lead cross-functional teams of engineers and SMEs, ensuring deliverables comply with relevant standards and regulations (cGMP, FDA, etc.).
  • Project Lifecycle: Manage a portfolio of projects covering focus areas such as combination product commercialization, process validation, and technology transfer.
  • Methodology: Utilize the Kymanox PM Toolkit™ and PMI best practices to drive project success.
  • Projects may include any of the following focus areas:
    • Combination Product Commercialization (e.g., Biologic-Device, Drug-Device)
    • Process and Product Development
    • Process Validation and Validation Planning
    • Process Improvement and Troubleshooting
    • Technical Report Authorship, Review, and Formatting
    • Manufacturing Investigations and CAPA/Deviation Closure
    • Biologic Manufacturing Scale-Up and Technology Transfer
    • FDA 483 and Warning Letter Remediation
    • Process and Facility Design to Support Next Gen Drug Manufacturing
    • Quality Management System Support
  • Perform additional responsibilities as requested or assigned.
• Client Relationship Management and Sales: Act as primary point of contact for multiple client stakeholders and manage opportunities for extensions of current SOWs and expansions into related service offerings at existing clients. Perform additional responsibilities as requested or assigned.
• PMO Operations
  • Internal Portfolio Management: Support PMO in oversight of Kymanox’s active project portfolio through maintenance of internal project trackers and project management systems.
  • Operations: Support other members of Kymanox leadership in creating reports, dashboards, and SOPs to enable improved project outcomes.
  • Perform additional responsibilities as requested or assigned.

Requirements

• Education: Bachelor of Science Degree in Chemical, Biomedical, or Mechanical Engineering, or related technical discipline from an accredited institution. Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, engineering, quality, or regulatory affairs preferred but not required.
• Experience:
  • Demonstrated aptitude and knowledge of project or program