(Contract) Technical Project Manager - Life Sciences

Position at Kymanox

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.

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