Associate Director, PD&C - Combination Products

Kymanox • Morrisville, NC

45d

About The Position

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. Leverages expertise in technical leadership and cross-functional management to advance, de-risk, and deliver successful outcomes for clients’ medical device and combination product development programs. Basic responsibilities include: 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. Projects may include any of the following technical areas: 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.

Requirements

• Minimum 15 years' experience in product development and/or manufacturing in the pharmaceutical (combination product), biotechnology, diagnostic, and/or medical device sectors is required. Direct experience with multiple device types is desirable.
• Leadership of complex, multi-disciplinary development programs, pharmaceutical (combination product) development, in vitro diagnostic development, clinical development, or electromechanical systems development is desirable.
• Executes high-profile activities with minimal supervision, drawing on a versatile and adaptable technical skill set
• Skilled in strategic planning and translating strategy into actionable processes
• Operates effectively within multiple client quality systems and product development frameworks concurrently
• Demonstrated ability identifying and implementing operational improvements
• Experienced with complex device systems, including software medical devices
• Highly detail-orientated and organized
• Strong professional presence with excellent presentation skills
• Confident in providing feedback and influencing internal and external stakeholders
• Collaborates effectively with remote team members and direct reports
• Self-motivated and inspires others to achieve goals
• Proactively identifies and resolves issues before they escalate
• Demonstrates both managerial (i.e., “do things right”) and leadership (i.e., “do the right thing”) skills
• Excellent verbal and written communication skills in English
• Innovative and creative mindset with a focus on continuous improvement
• Seasoned soft skills – high emotional intelligence (EQ) and strong team player
• Expert-level statistical analysis of development and production data, strong preference for experience in reliability
• Experience working with device software and cybersecurity risk assessments
• Technologically savvy, comfortable with modern IT tools and productivity software
• Thrives in fast-paced, dynamic, and growth-oriented environments
• Experienced engaging subject matter experts and effectively leveraging their input
• Understands and values, quality and regulatory compliance
• Uncompromising honesty and integrity

Nice To Haves

• The ideal candidate will have an advanced 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, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.
• Experience working at startup companies or small biotech/pharma/med device companies and familiarity with government and private sector funding mechanisms is highly favorable.
• Experience working in professional services is favorable.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees