Associate Director, Medical Devices And Combination Products

JOB DESCRIPTION

We are seeking a growth and continuous Improvement minded Associate Director in Device Technology that can help drive our Strategic Operating Priorities.

• Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

SUMMARY

The Associate Director in Device Technology is a key member of the device enabled combination product commercialization and its life cycle management with responsibilities supporting the product development teams, internal and external manufacturing network and sustainment of Medical Devices and Combination Products globally.
Experience in design controls, device risk management, medical device, Combination Products, prefilled syringes, change controls, deviation management, and related scientific/technical concepts and techniques are a must for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The Associate Director will routinely face competing priorities, and must manage time effectively, while keeping stakeholders and team members informed with effective communication.
This individual is expected to lead global and site-specific projects, including those related to Combination Products and Drug Delivery Systems, leading significant investigations, product quality complaint management, supporting regulatory inspections and proactively identifying issues. The role includes leading, enabling or consulting in the development and execution of related strategic plans for problem-solving and continuous improvement by working with internal and external partners.
The key stakeholders include our Company Manufacturing sites, External Manufacturing, new product development groups, Quality, Operations, Regulatory Affairs, Procurement, and suppliers.

EDUCATION

• Required | Technical BS degree or higher
• Preferred | BS, MS, or Phd in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar

REQUIRED EXPERIENCE

• Eight years of relevant experience in Medical Devices or Combination Products.
• Experience with medical device or combination product commercialization like prefilled syringes and/or technical operations.
• Experienced in change control, deviation management and leading significant investigations.
• Experienced in managing product life cycle management in post market space including capacity extensions.
• Experienced in supporting regulatory inspections.
• Proficiency in project management
• Proven ability to lead team members of diverse skill sets and backgrounds.
• Experience in working with cross functional and global manufacturing sites.
• Principled verbal and written communications

PREFERRED EXPERIENCE

• Experience in design controls, ISO 13485, deviation management, change control, risk management/ISO 14971-2019 and the fundamentals of documentation structure/systems.
• Working knowledge of ISO 11608 and ISO 11040
• Experienced drug device combination product development for small molecules, large molecules, or vaccines
• Demonstrated technical leadership to medical device and Combination product manufacturing sites and functional areas, including the authoring of GMP documents.
• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.
• Experience with autoinjectors or other complex drug-delivery systems and associated pre-filled syringe/cartridge components.
• Experience in working with medical device suppliers.
• Experience in commercialization of high-volume Medical Devices or Combination Products.

TRAVEL REQUIREMENTS:

10%

PRINCIPAL RESPONSIBILITIES

• Facilitate technology transfer and represent Device Technology as Product steward in life cycle management of Combination Products.
• Work Independently and as a Team member with Integrity.
• Complete all activities with the highest regard for all our Company divisional and local site procedures for safety, quality, and regulatory compliance.
• Utilize device risk management tools to build device or combination product risk management programs in development and life cycle management.
• Utilize design control experience to develop value-add solutions to customer needs in Medical Devices and Combination Products
• Technical support for product quality complaints.
• Secure early sponsorship and stakeholder alignment for projects and initiatives.
• Demonstrate the necessary Inclusion skills to integrate inputs and perspectives from various sources and communicate the decision to key stakeholders and sponsors.
• Lead technical investigations of Medical Devices and Combination product needs for commercial products.

EMPLOYEES WORKING IN ROLES THAT THE COMPANY DETERMINES REQUIRE ROUTINE COLLABORATION WITH EXTERNAL STAKEHOLDERS, SUCH AS CUSTOMER-FACING COMMERCIAL, OR RESEARCH-BASED ROLES, WILL BE EXPECTED TO COMPLY NOT ONLY WITH COMPANY POLICY BUT ALSO WITH POLICIES ESTABLISHED BY SUCH EXTERNAL STAKEHOLDERS (FOR EXAMPLE, A REQUIREMENT TO BE VACCINATED AGAINST COVID-19 IN ORDER TO ACCESS A FACILITY OR MEET WITH STAKEHOLDERS). PLEASE UNDERSTAND THAT, AS PERMITTED BY APPLICABLE LAW, IF YOU HAVE NOT BEEN VACCINATED AGAINST COVID-19 AND AN ESSENTIAL FUNCTION OF YOUR JOB IS TO CALL ON EXTERNAL STAKEHOLDERS WHO REQUIRE VACCINATION TO ENTER THEIR PREMISES OR ENGAGE IN FACE-TO-FACE MEETINGS, THEN YOUR EMPLOYMENT MAY POSE AN UNDUE BURDEN TO BUSINESS OPERATIONS, IN WHICH CASE YOU MAY NOT BE OFFERED EMPLOYMENT, OR YOUR EMPLOYMENT COULD BE TERMINATED. PLEASE ALSO NOTE THAT, WHERE PERMITTED BY APPLICABLE LAW, THE COMPANY RESERVES THE RIGHT TO REQUIRE COVID-19 VACCINATIONS FOR POSITIONS, SUCH AS IN GLOBAL EMPLOYEE HEALTH, WHERE THE COMPANY DETERMINES IN ITS DISCRETION THAT THE NATURE OF THE ROLE PRESENTS AN INCREASED RISK OF DISEASE TRANSMISSION.

Current Employees apply HERE
Current Contingent Workers apply HERE