Kymanox Careers

Description

• Provides technical leadership to client-facing Kymanox project teams with accountability for project strategy, execution, success, and client satisfaction.
• Plans and ensures execution of combination product development activities. Monitors and supports-hand on quality and progress of work, providing technical support and direction to project teams and individuals. 

• Author and/or reviews technically complex documentation to ensure compliance with relevant standards and regulations. 

• Directly support and provide subject matter expertise related to a range of engineering disciplines. 
• Proactively manage client relationships and ensure client satisfaction
• Contribute to the growth and success of the organization. Identifies and supports internal business initiatives to improve Kymanox processes and practices. 
• Provides mentorship and development opportunities to junior resources, as part of cross-functional projects. 
• Ensures conformance to both Kymanox and external compliance standards. 
• Management of direct reports is not in scope of this role at the time of hire. However, organizational growth may allow for the role to expand to managerial responsibility of 1-5 direct reports. Successful candidates for this position will be experienced in leading and mentoring junior staff. 

• Evaluate client technical documentation and strategy to provide clear, actionable recommendations for product design, development, and commercialization activities.
• Provide Quality Engineering support across product development activities, including design controls, process development, deviation investigations, CAPAs, and compliance with applicable quality system requirements. 
• Conduct competitive landscape assessments and market analyses for delivery devices, contract organizations, and novel technologies.
• Serve as a device lead for combination product development programs, with a good understanding of Chemistry, Manufacturing, and Controls (CMC) requirements across clinical and commercial stages.
• 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.
• Provide Regulatory Affairs support for clinical and commercial submissions, including submission strategy, technical documentation review, and coordination of global regulatory deliverables.

• The candidate will have at minimum a bachelor’s degree in engineering such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering, or a science-related field. 

• 8+ years’ experience in the medical device, pharmaceutical, or combination products industry (this includes post graduate experience). 
• Direct experience with pre-filled syringes, autoinjectors, co-packaged kits, inhalers, other drug delivery platforms, and/or other combination product platforms is required. 
• Strong track record across several of the Areas of Expertise listed above, with the ability to provide senior technical leadership and support within these areas.
• Experience working at startup companies or small biotech/pharma/med device companies and/or experience working in professional services is favorable.

• Motivated team player with a high sense of ownership and willingness to learn 
• Operates effectively within multiple client quality systems and product development frameworks concurrently with minimal supervision
• Self-motivated and inspires others to achieve goals
• Excellent verbal and written communication skills in English. Any other language is a plus. 
• Strong professional presence and verbal presentation skills
• Collaborates effectively with remote colleagues and clients. Confident in influencing internal and external stakeholders
• Seasoned soft skills – high emotional intelligence (EQ) and strong team player
• Understands and values, quality and regulatory compliance
• Highly detail-orientated and organized
• Uncompromising honesty and integrity