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(Contract) Senior Project Manager - CMC and Biologics
KymanoxUnited States, United Statesfull_timeVerifiedPosted 17 Mar 2026
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 Senior Project Manager will have a strong technical and/or operations background in cGMP manufacturing in the pharmaceutical, biologic, medical device, or combination product industries. Responsibilities:
- Provides technical project management support on client projects, inclusive of scheduling, meeting management, action item and decision tracking, risk management, and budget oversight
- Oversees the cross-functional team assigned to projects and owns project resource allocation and budget forecasting for assigned projects
- Ensures project deliverables are completed in compliance with relevant standards and regulations
- Serves as the primary point of contact on multiple client projects, and may also serve as technical lead if experience allows
- Creates project management deliverables with minimal oversight from management
- Follows Kymanox and client policies and standard operating procedures
- Provide a wide range of support on a portfolio of one to five projects covering a wide range of engineering, compliance, and commercialization challenges.
- Provide project leadership utilizing the Kymanox PM Toolkit™ and integrating the support of multiple engineers and experienced SMEs. 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.
- Perform additional responsibilities as requested or assigned.
- 4+ years Project Management or Program Management
- 7+ years of proven experience in the biopharma and/or medical device industries (i.e., Life Science) with knowledge in two or more of the following practice areas:
- CGMP Manufacturing (Pharma, Biotech, Device)
- Validation (Equipment, Facility, Utility, Process, Cleaning, Method, Computer)
- Quality Engineering
- Process Engineering, Technical Services, Manufacturing Sciences
- Quality Control or Analytical Science
- Quality Assurance
- Regulatory Affairs
- Technology Transfer
- Clinical or Medical Services
- Late Stage Process or Product Development (Pharma, Biotech, Device)
- Project Management in accordance with PMI.org and Kymanox best practices
- Experienced in use of Project Management tools, such as Smartsheet, Microsoft Project, and Office Timeline
- Works cooperatively in a matrixed team environment
- Able to lea
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