Principal Scientist I/II, Biologics Drug Product 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 .

Overview
The Development Sciences Drug Product Development (DevSci DPD) organization within AbbVie develops and characterizes drug product formulations, combination products and manufacturing processes to provide clinical dosage forms and devices to enable the development of AbbVie's pipeline, and ultimately to provide commercial drug products, combination products and commercial manufacturing processes.

AbbVie is seeking a highly motivated and experienced scientist with a proven track record in formulation and process development to serve as a Principal Research Scientist I in NBE Development reporting to the Director of NBE Development in Lake County, IL. The Principal Research Scientist I, NBE Development role within DPD is responsible for the design, development, optimization and tech transfer of manufacturing processes for parenteral drug products including monoclonal antibodies, antibody-drug conjugates, and sterile small molecules in the AbbVie pipeline.

This position will be an integral part of the product development teams and will have strong collaboration with the Preformulation and Analytical functions, the Drug Product Pilot Plants, third party manufacturers and AbbVie's Operations Commercial Manufacturing functions. The Principal Research Scientist I will lead formulation and process development programs in Lake County, IL and may have direct reports.

Key Responsibilities:

• Lead teams developing the drug product process for products within the AbbVie pipeline.
• Advance scientific expertise within function. Proactively demonstrate leadership by advising and sharing knowledge and expert opinions with subordinates, peers, and senior management.
• Mentor and train functional colleagues and assess current and emerging business challenges enabling functional goal achievement.
• May supervise one or more direct reports and engage proactively in their development. Evaluate staff performance and actively support staff development.
• Ensure group provides engineering impact to all development projects and deliverables are completed within established timelines, budgets, resources, and in accordance with regulatory, quality, and safety requirements.
• Ensure development of technologies that drive engineering excellence and scientific innovation that improve the future capabilities and productivity of the greater organization.
• Collaborate with other functions within AbbVie to align a broad range of strategies that directly support drug development programs; these include but are not limited to other areas in Development Sciences, Drug Product Development, Regulatory Affairs and Commercial Manufacturing Operations.
• Source and identify emerging scientific trends from multiple internal and external sources and assess relevance. Integrate trends into functional short-term objectives. Advance cross-discipline technology and direction through generation of data.
• Accountable for scale-up activities, design space definition and technology transfer to commercial plant.
• Ensure compliance with AbbVie safety, quality and regulatory policies and government regulations.
• Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
• Recognized and sought out as an expert in his/her discipline within the company and externally.

Qualifications

Basic Qualifications:

• Bachelors, Masters, or PhD in Engineering, Pharmaceutical Sciences, or related field with typically 14+ (Bachelors), 12+ (Masters), or 6+ (PhD) years of related work experience.
• Experience in research and/or development environment.
• Demonstrated leadership of technical teams and effective cross-functional communication.
• Proven ability to solve critical business and scientific problems.
• Extensive experience in drug product formulation and process development including scale-up from pilot plant to a commercial facility.
• Familiarity with operation of biologics drug product process equipment and systems.
• Strong technical background in sterile drug product manufacturing unit operations including freeze/thaw, mixing, sterile filtration, lyophilization, and filling.
• Understanding of cGMP, regulatory and process safety requirements.
• Familiarity with process modeling approaches such as CFD, FEM and phenomenological or first-principles models.

Preferred Qualifications:

• Advanced degree in Pharmaceutical Sciences or Engineering

Key Competencies:

• Effectively communicates to influence others, develops team members, drives technical excellence, and inspires continuous improvement.
• Builds strong relationships with peers and cross-functional partners to enable higher performance.
• Connects ideas from disparate fields, integrates data and information quickly, and takes risks to achieve the highest performance.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Significant Work Activities
N/A
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.