Principal Engineer Process Development I

Overview:

The AbbVie Combination Product Development and Drug Delivery (CPDDD) 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 frontend 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. AbbVies delivery system portfolio ranges from simple oral syringes or dosing cups to progressively more complex ones such as eyecare dropper bottles prefilled syringes autoinjectors patch pumps and continuous subcutaneous infusion pumps.

The growth of therapeutics that require a delivery device and increasing engagement of CPD in earlystage 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 AbbVies therapeutic pipeline.

Responsibilities:

This role is intended to support the CPD L&PD groups 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 crossfunctional 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 thirdparty development partners outside of the United States and this individual is expected to foster the ongoing relationship. Thus the role requires periodic facetoface 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 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 38 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 fastpaced environments
• Ability to influence and negotiate internally and externally as a part of global team
• Strong problemsolving and analytical skills
• Working knowledge with medical devices and medical device regulations and standards is preferred
• Travel will be required as necessary 1020

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 shortterm incentive programs. 

• This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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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Work :

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