Principal Program Manager

Job Description:

I s 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 Kymanox Program Management Office is seeking a  Principal Program Manager  with a strong technical and/or operations background in the pharmaceutical, biotechnology, or medical device industries. Ideal candidates will build on their proven past performance supporting complex product development or life cycle management programs involving drug-device combination products.

This position is hybrid with an average of 3+ days of week at the Kymanox office in King of Prussia, PA.

Job Description:

The Principal Program Manager is the client-facing lead for a portfolio of two to five projects or one to two programs focused on drug-device combination products, and is accountable for their execution and success. The role combines program leadership with hands-on technical direction. It focuses on early-phase device design and innovation and/or on design verification (DV) and testing strategy supporting combination product Design History Files (DHFs). The Principal Program Manager also mentors and develops junior and mid-level staff and is expected to grow into direct people management within the PMO. Work may take place at client sites, at a Kymanox office, or remotely.

Program Leadership and Delivery

- Serve as the primary point of contact and accountable lead for multiple client projects or programs.
- Develop project plans, schedules, and overall program strategy, then drive execution to deliver on scope, schedule, and budget.
- Lead core project management activities, including stakeholder and risk management, schedules, dashboards, budget tracking, meeting minutes, and client correspondence.
- Build fit-for-purpose project management tools where standard tools fall short.
- Delegate work to internal and external teams and monitor deliverable quality and progress.

Combination Product Technical Leadership

- Act as technical lead on smaller programs or lead technical workstreams on larger programs, as needed.
- Guide early-phase device development, including user needs, design inputs, device and technology selection, feasibility work, and design reviews through design freeze.
- Plan and oversee DV programs, including test strategy, test method development and validation, protocol and report review, and traceability from requirements to verification evidence.
- Author, review, and remediate DHF content and other technical documentation with minimal oversight.
- Assess client documentation and development strategies, and deliver clear, actionable recommendations for mitigating gaps.

People Leadership and Development

- Mentor junior and mid-level program managers and engineers and review their work before client delivery.
- Coach and develop team members, with the expectation of taking on direct reports as the PMO grows.
- Oversee team capacity and project assignments in partnership with PMO leadership.

Practice Building and Compliance

- Develop project management best practices and drive their adoption across the company.
- Collaborate cross-functionally within Kymanox and with client organizations.
- Uphold regulatory standards and model a positive compliance culture.

Aptitude and Skill Set:

- Versatile and adaptable technical skills
- Able to execute high-profile activities with minimal supervision, manages time wisely and delegates as necessary
- Positive attitude, and welcomes new challenges
- Flexible to be present at client sites and sometimes travel
- Strong professional presence and presentation skills
- Extremely detail-orientated and highly organized
- Excellent written and oral English communication skills
- Comfortable providing feedback and influencing internal and external stakeholders
- Emotionally stable and can navigate challenging clients and situations
- Seasoned soft skills – high EQ and team player
- Ability to work effectively with remote team members
- Tackle problems proactively
- A mindset of innovation and creativity
- Proficient in hands-on lab operations and competent in GLP/ GDP
- Computer and IT savvy
- 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

Educational Background:

Minimum bachelor's degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution. Industry certificates in project management (e.g., PMP), six-sigma, quality, or regulatory affairs preferred but not required.

Experience:

- 10+ years in the biopharma and/or medical device industries, including 7+ years working directly on drug-device combination products (e.g., prefilled syringes, autoinjectors, pen injectors, on-body injectors, infusion pumps, nasal sprays, inhalers). Consulting or client-facing experience is preferred.
- 7+ years of project or program management, including at least 3 years as the accountable lead for cross-functional device or combination product development programs. PMP certification is preferred.
- 3+ years mentoring and leading others, formally or informally, including reviewing technical work, providing constructive feedback, and coaching or oversight of professional development initiatives. Direct people management experience is preferred.
- Demonstrated leadership in at least one of the following technical subject matters: Early-phase design and innovation: leading concept-through-design-freeze work, including user needs, design inputs, device selection, feasibility assessment, and design reviews.
- Design Verification and Device Testing Management: planning and managing design verification programs, test method development and validation, testing protocol and report authorship, traceability matrices, and DHF compilation or remediation.

- Working knowledge of combination product and design control requirements. This includes 21 CFR Part 4, FDA’s Quality Management System Regulation (21 CFR Park 820 / ISO 13485), ISO 14971, and relevant device standards such as ISO 11608 and ISO 11040.
- Significant contributions to complex, multi-disciplinary development programs, pharmaceutical (drug product) development,  in vitro  diagnostic development, clinical development, or medical device/electromechanical systems development is desirable.

Region:

King of Prussia, PA

Travel:

Travel may be necessary to support client work. Periodic visits (e.g. 1-2 visits per year) to other Kymanox office(s) are required.

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.

About Kymanox:

Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.

To learn more about our company, please visit our website:   Life Science Solutions | Kymanox

Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.