Associate Director / Director, Device and Packaging Development

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

As Associate Director / Director, Device and Packaging Development, you will join a talented, diverse team of engineers and scientists responsible for the design and development of drug delivery devices and primary and secondary packaging for combination products.  This position will be responsible for technical leadership on development projects, as well as building new capabilities and driving business process improvements in collaboration with partner functions and stakeholders. The ideal candidate has proven depth of experience in combination product development across the product lifecycle from technology assessment through commercialization, and a robust understanding of relevant regulatory, quality and manufacturing requirements.  Superb communication, influencing and leadership skills are critical.   

Responsibilities

• Responsible for the assessment, development and recommendation of delivery device and packaging solutions in support of the AbbVie pharmaceutical and Medical Aesthetics businesses.
• Leads the Device sub-team for one or more development projects, working closely with other Development Sciences functions, Science & Technology, Regulatory Affairs, Project Management, Manufacturing Operations, Quality, Clinical and Marketing to meet project objectives, timelines, and budgets.
• Applies sound scientific, engineering, and regulatory knowledge for the planning and execution of product development activities.
• Constructively leverages internal and external networks to maintain up to date knowledge of state-of-the-art packaging and device solutions, access new capabilities, and reduce them to practice.
• Develops, aligns and implements new business processes in partnership with relevant functions and stakeholders.
• Responsibilities may include supervision of exempt and non-exempt technical personnel, and development of a pipeline of diverse talent within the organization.
• May represent Abbvie in negotiation with regulatory agencies and support product acquisition due diligence activities. 
• Fosters a culture of continuous improvement and conceives/leads initiatives to ensure functional excellence and efficiency.
• Develops and maintains a current in-depth knowledge of global regulatory submission and GLP/GMP requirements
• Provides oversight of external partners; manages vendors and CMO’s in both development of new products, and manufacturing activities.

Job level will be commensurate with experience

Qualifications

Education and Experience:

• B.S. Degree in Engineering, Materials Science, or related discipline with typically 10-15 years of experience in combination product and/or packaging development, or an Advanced degree with typically 7-10 years of experience. 
• Experience in direct supervision and development of technical staff preferred.
• Demonstrated track record in the development of combination products across the product lifecycle, from technology assessment to commercialization.
• Recognized as a technical expert with deep knowledge of device product development and/or container closure and secondary packaging development, Design Controls and Risk Management methodologies, and their application to combination product development.
• Previous experience successfully managing multidisciplinary project teams to meet program milestones, timelines and budgets.

Essential Skills and Abilities:

• Ability to lead complex technical investigations and develop workable solutions to difficult problems.
• Ability to think strategically, integrate diverse inputs and perspectives, articulate risk/benefit implications to key stakeholders, and drive timely, high quality decisions.
• Knowledge of container closure integrity testing methods and transit testing standards, Design for Manufacture and scalability, and statistical methods and data analysis tools, including DoE.
• Knowledge of regulatory requirements for combination products worldwide, including US FDA regulations and EU-MDR.
• Ability to assess technical opportunities and to make appropriate assessments and recommendations to management.
• Excellent critical thinking, problem-solving, and organizational skills
• Superb oral and written communication and influencing skills

Key Leadership Competencies

• A team attitude with a positive outlook is a must.
• Ability to balance competing priorities and thrive in a dynamic, fast-paced environment.
• Operates with an enterprise perspective
• Inspires and motivates others toward a shared purpose
• Knows the business and the cross-functional contributions needed to deliver results
• Makes timely, high-quality decisions with less than perfect information
• Sets clear strategies and robust implementation plans
• Creates an environment in which people appropriately experiment and challenge the status quo

Significant Work Activities
N/A
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.