Senior Scientist III, Process Engineering Sciences
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.
The Senior Scientist III, Process Engineering Sciences role within DPD is responsible for the design, development, optimization and transfer of manufacturing processes for oral drug products in the AbbVie pipeline.
AbbVie is seeking a highly motivated and experienced scientist with a proven track record of process development to serve as a Senior Scientist III in Process Engineering Sciences reporting to the Associate Director of Process Engineering Science in Lake County, IL.
This position will be an integral part of the product development teams and will have strong collaboration with the GPSc Formulation and Analytical functions, the Drug Product Pilot Plants, and the Operations Commercial Manufacturing functions. The Senior Scientist III will lead process development programs in Lake County, IL and may have direct reports.
- Lead the drug product process development of 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 assesses current and emerging business challenges enabling functional goal achievement.
- 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 discovery and 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 possibly externally.
Level and compensation will be commensurate with experience
- Bachelors, Masters, or PhD in Engineering or related field with 12+ (Bachelors), 10+ (Masters), or 4+ (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 process development and scale-up from pilot plant to a commercial facility
- Familiarity with operation of oral dosage form process equipment and systems
- Strong technical background in oral drug product manufacturing unit operations including blending, wet- and dry-granulation, tableting, film-coating, milling and extrusion
- Understanding of cGMP, regulatory and process safety requirements
- Experience with Process Analytical Technologies, Continuous Manufacturing, and process modeling
- Advanced degree in Engineering
- Ability to communicate and 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