Principal Engineer, Process Development I

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Overview:

The AbbVie Combination Product Development and Drug Delivery (CPD-DD) group provides design and development expertise to enable drug delivery systems for AbbVie biopharmaceuticals. The Landscaping & Platform Definition (L&PD) group within CPD is the team that does the "front-end" needs assessment for delivery systems. This group collects the business and technical delivery needs for future drug delivery systems, identifies potential candidate delivery system options, and conducts the feasibility assessment to narrow the list of candidate delivery systems to promising ones that best fit those needs. AbbVie's delivery system portfolio ranges from simple oral syringes or dosing cups to progressively more complex ones such as eyecare dropper bottles, pre-filled syringes, autoinjectors, patch pumps, and continuous sub-cutaneous infusion pumps.

The growth of therapeutics that require a delivery device and increasing engagement of CPD in early-stage clinical development drive the need for additional expertise in the L&PD group. This group will also assess if a delivery technology could potentially meet the needs of multiple future AbbVie assets and could be considered a platform.

We are looking for an individual based in Lake County, IL, US with an understanding of delivery systems, a knowledge of design control, and the ability to systematically approach a needs definition process to support identification of future delivery systems to support AbbVie's therapeutic pipeline.

Responsibilities:

This role is intended to support the CPD L&PD group's need to manage future delivery system needs. This individual will work alongside Product Development Directors in CMC, as well as Asset Teams and the Commercial organization to identify future delivery needs for drug assets still in early clinical development. This individual will work with a global cross-functional team to broaden the understanding and implementation of appropriate product and platform development principles within the established processes. This individual will collaborate with internal partners as well as external organizations and potential partners. The work with external partners involves the development of relationships with third-party development partners outside of the United States, and this individual is expected to foster the ongoing relationship. Thus, the role requires periodic face-to-face visits in addition to regular teleconferences.

The individual will perform the following activities:

• Support the identification of patient needs
• Support the development of business and technical needs for the delivery system
• Maintain familiarity with various external delivery system manufacturers
• Support the development of a landscape of commercially available delivery system options and potential candidates
• Evaluate the landscape and identify leading candidates, based on technical fitness and business criteria
• Scope feasibility assessment needs (e.g., for dose accuracy), request proposals and manage the budgets
• Support the development of feasibility contracts with external firms
• Support the development of preliminary timelines for execution - feasibility and development.
• Support decisions to proceed to feasibility

Qualifications

Qualifications:

• BS, MS, or PhD in Mechanical, Biomedical or related engineering discipline.
• Strong working knowledge of design control and combination product and device development
• 14+ years (with BS), 12+ years (with MS) or 6+ years (with PhD) experience in product development experience with a minimum of 3-8 years in medical devices and drug delivery. This experience should span design, development, verification and validation
• Experience development delivery system platforms is a plus
• Excellent written and spoken communications skills
• Ability to work with a variety of disciplines and teams in fast-paced environments
• Ability to influence and negotiate internally and externally as a part of global team
• Strong problem-solving and analytical skills
• Working knowledge with medical devices and medical device regulations and standards is preferred
• Travel will be required, as necessary (10%-20%)

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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