(Contract) Technical Project Manager - Life Sciences
Description
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 Technical 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 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:
- 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.
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:
- 2+ years Project Management or Program Management
- 4+ 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)
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
- 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
Travel:
Local travel within the assigned region and surrounding areas is required. Up to 30% domestic and international travel may be required from time to time.
Compensation:
Hourly rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.