AbbVie Process Development Engineer, New Biologic Entities in Lake County, Illinois
The pharmaceutical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state of the art formulation, processing and analytical technologies. We create intellectual property through new formulation compositions, lean and smart manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content. We are looking for a highly motivated person who supports and drives process development activities for NBEs. The candidate will develop manufacturing processes for biologics and maintain as well as improve our technological equipment to expend the state-of-the-art. Furthermore, the candidate will design experimental approaches to answer scientific questions to develop and optimize NBE drug product manufacturing processes in-house and at external partner. Working closely with analytical and formulation scientists in an integrated group the candidate will develop productive collaborations and communications with scientific teams.
•Participating in and driving the process development of parenteral formulations for biologics with a focus on antibody drug conjugates. •Being the first point of contact for the operation of advanced NBE process technologies with special emphasis on vial- and syringe filling processes and annexed technologies like lyophilization. •Supports scale-up activities and tech transfer to the NBE pilot plant and to external partners. •Continuous thorough maintenance (mechanical, electrical) of process and laboratory development equipment and trouble shooting of technical issues on the machines. •Builds strong relationships to other functional units (e.g. S&T, combination products, process engineering) and supports / advises activities in collaboration with partners. •Optimize laboratory operations for efficient use of time and resources. •Expected to recommend improvements in design, installation or execution of a project or task and continuously scout for related technologies to improve equipment and processes. •Document experimental data thoroughly in lab documentation systems, make concise scientific presentations of process results and author detailed scientific technical reports. •Responsible for compliance with all applicable AbbVie policies and procedures. •Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
Level and compensation will be commensurate with experience.
Basic: • BS (3 years) or MS (0 years) in engineering or related discipline with previous laboratory or technical experience. • Experienced in mechanical or electrical trouble shooting of complex electromechanical systems. • Experienced in laboratory systems (ELN) preferred. • Experience in Microsoft Office (Excel, Sharepoint, PowerPoint, and Word) required. • Statistical knowledge and experience is preferred e.g. capability analysis or design of experiments (DOE) methodologies.
Preferred: • BS (5 years) or MS (3 years) in engineering or related discipline with previous laboratory or technical experience.*
Key Leadership Competencies: • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. • Learns fast, grasps the "essence" and can change course quickly where indicated. • 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.
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Travel: Yes, 5 % of the Time
Req ID: 1703620
Equal Opportunity Employer Minorities/Women/Veterans/Disabled