(Contract) Senior Project Manager - CMC and Biologics

Kymanox is a company focused on improving patient outcomes through expert project management in the biopharmaceutical and medical device industries. The Senior Project Manager will oversee technical project management support, ensuring compliance with standards and managing cross-functional teams on client projects.

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

Requirements:

• Bachelor of Science Degree in Chemical, Biomedical, or Mechanical Engineering, or related technical discipline from an accredited institution
• 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 lead high-profile projects with minimal supervision
• Extremely detail-orientated and highly organized
• Managerial (i.e., 'do things right') and Leadership (i.e., 'do the right thing') skills
• Strong professional presence and presentation skills
• Excellent written and oral English communication skills
• Fast learner with initial confidence tackling new material
• Seasoned soft skills – high EQ and team player
• Ability to motivate self and others
• Tackle problems proactively, not waiting for problems to grow unnecessarily
• Thrive in a fast-paced, growing, and dynamic work environment
• Expertly solicit and utilize subject matter expert input
• Value and understand quality
• Uncompromised honesty and integrity
• Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, engineering, quality, or regulatory affairs