(Contract) Senior Project Manager - Combination Products

Kymanox•Boston, MA

1d•Onsite

About The Position

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 drug-device combination product development, including manufacturing oversight and design controls.

Requirements

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)
Bachelor of Science Degree in Chemical, Biomedical, or Mechanical Engineering, or related technical discipline from an accredited institution
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

Nice To Haves

Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, engineering, quality, or regulatory affairs preferred but not required.

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.