AbbVie Device Engineering & Commercialization Director in Lake County, Illinois
The Director will oversee the device, primary and secondary packaging aspects of combination product molding, assembly and site launch readiness / commercialization. This person will lead both on market device support and new device launch efforts for injection system including on body delivery systems, auto-injectors and pre-filled syringes. The leader will extensively work with internal and external partners to assure that all device molding, assembly equipment and sites are in compliance with current Good Manufacturing Practices (cGMP) and optimized to meet all business goals.
- Lead feasibility, development, qualification for launch and on market support of device development, particularly for parenteral devices such as prefilled syringes, auto injectors and large volume bolus injectors.
- Represent MES during device design, device target setting, characterization; provide expertise in CAD software (e.g. solid works) and knowledge of industry standards (e.g. ISO, AAMI, ANSI).
- Lead risk assessment and failure mode analysis for equipment and related molding and assembly activities.
- Provide support to all on market device-related initiatives.
- MES lead for development of design controls; both development and manufacturing.
- Prepare capital plans and LRP for device related engineering activities.
- Oversee molding and assembly equipment installation, commissioning and qualification activities
- Ensure all validation activities are conducted in line with AbbVie and Quality requirements to meet business targets for launch readiness.
- Oversee the implementation and management of training programs for combination products including leadership, business curriculum and training plans.
- Prepare and present progress and significant events for executive, cross-functional management review.
- Masters in Engineering or related technical field.
- 10 years of experience in the combination product or medical device industry with proven experience in developing and commercializing combination products with injection system; broad experience in human factors studies, design verification/validation and usability studies.
- Leadership of technical professionals; proven effective leader to cross-functional teams with focus on commercialization, equipment selection, build and qualification of devices.
- On-body delivery systems, auto-injectors, pumps and pre-filled syringe NSP and smart packaging design experience required.
- Skilled in the initiation, selection, coordination and management of projects and have the ability to solve unique problems.
- Requires an in-depth understanding of the pharmaceutical product development cycle.
- Site commercialization, project management and qualification experience is 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 in-depth 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).
Interface w/ AbbVie Sr Leaders (Directors & VPs) from Operations Mfg, Eng. S&T, Purchasing, Finance, QQ; R&D Development & Pipeline Teams, Regulatory Affairs.Represents AbbVie & Operations w/external partners including Third Party Mfg executives
Job Classification: Experienced
Primary Location: USA-Illinois-Lake County
Travel: Yes, 25 % of the Time
Req ID: 1701039
Equal Opportunity Employer Minorities/Women/Veterans/Disabled