Combination Products Project Manager

Kymanox•King of Prussia, PA

About The Position

The Combination Products Project Manager provides technical project management support for a portfolio of 1–5 life sciences projects addressing development, compliance, and commercialization challenges. The role leads cross-functional teams and oversees project schedules, budgets, risks, resources, and deliverables to support compliance with applicable standards and regulations, including cGMP and FDA requirements. Projects may span combination product commercialization, process and product development, validation, manufacturing, technology transfer, quality systems, and regulatory remediation. The position also supports client relationships and sales opportunities, as well as Kymanox’s internal project portfolio and PMO operations. The position may evolve over time, with additional responsibilities and opportunities for advancement within the role or other organizational functions. Up to 10% domestic and international travel may be required. Compensation is based on experience, qualifications, interview considerations, and market conditions; the role may be eligible for an incentive program after six months of outstanding work.

Requirements

Bachelor of Science degree in Chemical, Biomedical, or Mechanical Engineering, or a related technical discipline, from an accredited institution.
Demonstrated aptitude and knowledge of project or program management.
Ability to work cooperatively in a matrixed team environment.
Strong interpersonal skills, including the ability to motivate teams and navigate client conflicts diplomatically.
Excellent verbal, written, and presentation skills, with a strong professional presence.
Ability to balance managerial execution with leadership judgment.
Ability to thrive in a fast-paced, growing, and dynamic work environment and lead high-profile projects with minimal supervision.
Strong attention to detail and organizational skills.
Ability to learn quickly and confidently tackle new material.
Proactive problem-solving approach.
Values and understands quality; demonstrates honesty and integrity.
Up to 10% domestic and international travel may be required.

Nice To Haves

Three to five years of direct project management experience in the life sciences industry.
Knowledge in two or more practice areas: cGMP manufacturing (pharma, biotech, or device); validation (equipment, facility, utility, process, cleaning, method, or computer); quality engineering; process engineering, technical services, or manufacturing sciences; quality control or analytical science; quality assurance; regulatory affairs; technology transfer; clinical or medical services; or late-stage process or product development (pharma, biotech, or device).
Advanced degree or industry certificates in project management (e.g., PMP or CAPM), Six Sigma, engineering, quality, or regulatory affairs.
Experience with project management methods in accordance with PMI.org and Kymanox best practices.
Experience using project management tools such as Smartsheet, Microsoft Project, and Office Timeline.

Responsibilities

Provide technical project management support, including scheduling, budget oversight, risk management, and resource allocation.
Lead cross-functional teams of engineers and subject matter experts, ensuring deliverables comply with relevant standards and regulations, including cGMP and FDA requirements.
Manage a portfolio of projects involving combination product commercialization, process validation, and technology transfer.
Use the Kymanox PM Toolkit™ and PMI best practices to support project success.
Support projects in areas including combination product commercialization; 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 for next-generation drug manufacturing; and quality management system support.
Serve as the primary point of contact for multiple client stakeholders and manage opportunities to extend current statements of work and expand related service offerings with existing clients.
Support PMO oversight of Kymanox’s active project portfolio by maintaining internal project trackers and project management systems.
Support Kymanox leadership in creating reports, dashboards, and SOPs to improve project outcomes.
Perform additional responsibilities as requested or assigned.