Associate Director, PD&C - Combination Products

Kymanox • Morrisville, NC

7d

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.

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
• Understands and values, quality and regulatory compliance
• Uncompromising honesty and integrity

Nice To Haves

• 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.
• 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
• Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.

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.

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.
• Eligible for incentive program after 6 months of outstanding work.

What This Job Offers

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