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Associate Director, PD&C - Combination Products
KymanoxMorrisville, United Statesfull_timeVerifiedPosted 18 Nov 2025
About the role
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 Kymanox Product Development & Commercialization team is seeking an experienced Associate Director with a strong technical and/or operations background in the pharmaceutical (combination product), biotechnology or medical device industries. Responsibilities:
- Provides senior technical leadership to external-facing Kymanox project teams with accountability for project strategy, execution, success, and client satisfaction.
- Plans and ensures execution of combination product development activities. Delegates and monitors quality and progress of work, providing technical support and direction to project teams and managers.
- Support sales calls and preparation of proposals by demonstrating knowledge and confidence in scoping activities.
- Identifies and supports internal business initiatives to improve Kymanox processes and practices.
- Collaboratively evaluates future business needs to derive and implement strategies to meet those needs.
- Provides mentorship and development opportunities to junior resources, as part of cross-functional projects or as direct reports.
- Functional management and leadership of direct reports within team.
- Responsible for team performance reviews and evaluations, mentoring and coaching, resource management, goal setting, time tracking and reporting.
- Ensures conformance to both Kymanox and external compliance standards.
- Performs technical and quality review of source documents.
- Directly supports and provides subject matter expertise.
- Representing Kymanox to clients as a subject matter expert and thought leader.
- Providing technical leadership and direction to internal and external project teams.
- Contributing to internal business improvement projects.
- Maintaining conformance to internal and client quality management systems.
- Adhering to regulatory standards and promoting a positive compliance culture.
- Providing mentorship to junior staff.
- Evaluate client technical documentation and strategy to provide clear, actionable recommendations for product design, development, and commercialization activities.
- Conduct competitive landscape assessments and market analyses for delivery devices, contract organizations, and novel technologies.
- Prepare detailed project plans, schedules, and overall development strategy.
- Management of technically complex, multi-year development programs.
- Oversee the creation of technical documentation supporting design controls, manufacturing processes, and regulatory submissions.
- Lead the preparation of risk management file documentation.
- Oversee phase-appropriate client testing activities, including combination product and medical device design verification and human factors testing.
- Direct design verification and the associated test method development and validation activities.
- Contract Manufacturing Organization (CMO) evaluation, due diligence, and selection on behalf of clients.
- Serve as an independent reviewer for client design review meetings throughout the product development process.
- Process development, improvement, troubleshooting, and design transfer.
- Provide technical support for regulatory submission preparation and review.
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