Program Manager, Engineering and Integration, Delivery Systems and Combination Products
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.
The Program Manager is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, Project Management, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Primary Packaging, Accessories, Secondary Packaging, Instructions for Use and Labeling). The Program Manager ensures that the strategy and plans defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and Asset team. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.
Summary of Responsibilities and Accountabilities:
The Program Manager will be accountable to the CMC team, the CMC Product Development Director and delivery system Senior Leadership for delivering on the strategy, plans and budget defined for the project portfolio.
- Leadership of a portfolio of drug delivery system product development projects
- Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners
- Organizes and leads monthly CPD Project Alignment Meeting (PAM)
- Drives demonstrated best project management practices across all CPD global locations
- Coordinates implementation of product development tools and training at local sites such as Linkus, Blueprint and CP Playbook processes
- Device financial management including budgeting, forecasting and long-range planning of delivery development expenses
- Representing the R&D organization to cross functional leadership through effective and timely communication
- Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions
- Driving continuous improvement on Program/project management processes and tools
- Direct management of project managers with responsibility for device/device constituent development projects
Management of External Partners: The Program Manager leads the team in managing the relationship and performance of key external device development partners. An effective and efficient development partner governance process should be defined and implemented including key interface definition, meeting cadence, schedule performance monitoring, project scope/change control, issue escalation, and financial tracking. Program risks must be identified and mitigated with the partner throughout the program lifecycle. The Program Manager will ensure timely and efficient communication regarding partner performance will be provided to the broader AbbVie organization as required. The Program Manager will work with the AbbVie contracts team and the partner to define and track performance to the Statement of Work. The Program Manager will provide accurate and timely cost estimates for budgeting and forecasting.
Impact on AbbVie: The role of Program Manager has broad influence and impact on the development and launch of AbbVie’s assets when a device/combination product delivery system is required. These device systems are often technically complex, involve multiple sub-systems, interface directly with the patient, and must meet global requirements. Typically, external partner management is required. The Program Manager must represent the R&D function to cross functional leadership through effective communication and use of influence skills
- Bachelor’s Degree in Engineering or related technical field with typically 14+ years of relevant experience or Masters Degree with typically 12+ years of relevant experience required.
- Master’s degree in Engineering or Business preferred.
- 10+ years of experience in the combination product, medical device and/or pharmaceutical industry preferred.
- Leadership of technical professionals; proven effective leader to cross-functional teams with focus on commercialization, equipment selection, build and qualification of delivery systems.
- Skilled in the initiation, selection, coordination, and management of projects and can solve unique problems.
- Requires an in-depth understanding of the pharmaceutical product development cycle.
- Design history file, project management and product development experience are essential.
- Conflict resolution skills including persuasive management techniques required. Effective communication and people management capability.
- Ensure timely execution of incoming reportable device combination product events to comply with global regulations.
- Must have working understanding and application of GMP principles, concepts, practices and standards as well as relevant related regulatory requirements for commercialization in diverse global markets (United States, Europe, Asia, Latin America).
- Up to 25% travel may be required to effectively manage communication between multiple Abbvie sites and third-party suppliers. Fluency in English and German is preferred.
Significant Work Activities
Yes, 25 % of the Time
Job Level Code
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.