Combination Products Project Manager

Description

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..

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:
  1. Combination Product Commercialization (e.g., Biologic-Device, Drug-Device)
  2. Process and Product Development
  3. Process Validation and Validation Planning
  4. Process Improvement and Troubleshooting
  5. Technical Report Authorship, Review, and Formatting
  6. Manufacturing Investigations and CAPA/Deviation Closure
  7. Biologic Manufacturing Scale-Up and Technology Transfer
  8. FDA 483 and Warning Letter Remediation
  9. Process and Facility Design to Support Next Gen Drug Manufacturing
  10. Quality Management System Support
  11. 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

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 management is required.
• Preferred: 3-5 years of direct Project Management experience in the life science industry.
• Preferred: Knowledge in two or more of the following practice areas:
  1. CGMP Manufacturing (Pharma, Biotech, Device)
  2. Validation (Equipment, Facility, Utility, Process, Cleaning, Method, Computer)
  3. Quality Engineering
  4. Process Engineering, Technical Services, Manufacturing Sciences
  5. Quality Control or Analytical Science
  6. Quality Assurance
  7. Regulatory Affairs
  8. Technology Transfer
  9. Clinical or Medical Services
  10. Late Stage Process or Product Development (Pharma, Biotech, Device)

Desired Aptitude and Skill Set:

• 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
• Seasoned soft skills with the ability to motivate teams and navigate client conflicts with diplomacy.
• Strong professional presence with excellent verbal, written, and presentation skills.
• Self-starter who balances "doing things right" (managerial) with "doing the right thing" (leadership).
• Ability to thrive in a fast-paced, growing, and dynamic work environment.
• Able to lead high-profile projects with minimal supervision
• Extremely detail-orientated and highly organized
• Fast learner with initial confidence tackling new material
• Tackle problems proactively, not waiting for problems to grow unnecessarily
• Thrive in a fast-paced, growing, and dynamic work environment
• Value and understand quality
• Uncompromised honesty and integrity

Travel:

Up to 10% domestic and international travel may be required from time to time.

Career Development:

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.

Compensation:

Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market conditions. Eligible for incentive program after 6 months of outstanding work.

Benefits:

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.