Technical Project Lead, Combination Product Development

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

ROLE SUMMARY

The Combination Product Development team is a dynamic, growing part of Kindeva’s Development Services organization. We have recently opened a facility in Germantown, MD and are seeking talented team members to help us provide customers in each major drug delivery combination product segment with a comprehensive offering of market-ready combination product platforms and world-class development service capabilities throughout the product lifecycle.

As the Technical Project Lead, Combination Product Development, you will lead development of drug delivery devices including autoinjectors. You will report to the Senior Director, Combination Product Development, and will provide technical leadership and subject matter expertise for combination products, specifically autoinjectors and/or alternative drug delivery devices.

This role will lead all development aspects including engineering, design, optimization, robustness, reliability for assigned projects. You will lead thorough debugging, and smooth design transfer. You will support scale-up for manufacturing, assembly process development and qualifications. This is a hands-on role, as we are a growing organization, and the ability to develop a strategic plan as well as build and lead a team will be critical.

This is a unique opportunity to have a direct impact on delivering final product solutions to our partners, patients, and have direct impact on the overall success of the organization.

We are building a culture of individuals who embody our PRECISE Values and expect you to lead with personal responsibility, respect, excellence, transparency, innovation, commitment, and energy.

ROLE RESPONSIBILITIES

• Lead the technical development of devices and combination products.
• Collaborate with internal departments and with external vendors and CDMOs to deliver combination product project according to project goals, timelines, and budgets.
• Communicate effectively with senior leadership, project teams, customers and suppliers.
• Use visual management techniques to communicate project strategy, risks, status.
• Provide engineering expertise to support cross-functional teams to collaboratively define and execute device and combination product process development and technology transfer activities.
• Responsible for Design History Files, Risk Analysis, FMEA, Device Master Records, Specifications, etc. on all combination products, sub-assemblies and components as required.
• Lead feasibility assessment, including prototyping, analysis and lab testing. Perform first principles analysis and modeling of key performance attributes of devices.
• Champions DFSS and CPD&M methodologies
• Lead technical risk management activities
• Lead investigations and manage change controls for new or improved designs for components, subassemblies and top-line assemblies.
• Develop project schedules, as needed, using MS Project and SmartSheet.
• Establishes and maintains an understanding of current trends and emerging technologies in the area of combination products, specifically autoinjectors.
• All work must be in compliance with regulations, company and customer requirements.
• The position will provide oversight of the development teams, ensuring proper use of assets, budget, and personnel and will write and deliver performance reviews and perform second level reviews as required.

BASIC QUALIFICATIONS

• A minimum of 7 years of pharmaceutical, device and/or diagnostics development
• BS required, MS preferred in engineering or relevant technical discipline including but not limited to biomedical engineering, mechanical engineering, or chemical/biochemical engineering.
• Experience in the development of autoinjectors, pre-filled syringes, or other combination drug delivery devices is required.
• Experience with Combination Product regulations, analytical chemistry and experience with auto injector design/function is required.
• Relevant combination product verification and validation experience utilizing global quality and regulatory standards such as 21 CFR 820, ISO 9000,13485 and 14971. Strong knowledge of prefilled syringe and autoinjector technical standards (e.g., ISO 13485, ISO 11608, ISO 14971) is required.
• Ability to work on-site in Germantown, MD
• Ability to do domestic and some international travel [up to 30%].

PREFERRED QUALIFICATIONS

• PMP certification
• Experience developing drug delivery devices for emergency use
• Experience developing drug delivery devices for military and/or first responder applications
• Expertise in Design for Six Sigma and CPDM methodologies
• Experience using SolidWorks
• Able to apply engineering skills and practices to gather user requirements and translate them into technical studies/assessments for drug delivery systems for characterization or qualification.
• Effective self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.