Process Research and Development invents chemical processes and prepares active pharmaceutical ingredient (API) to enable clinical trials, toxicology studies, and drug product development for AbbVie’s pre-clinical and clinical drug pipeline. In addition to working with small molecules, Process R&D also develops antibody drug conjugates (ADCs). We create valuable intellectual property through composition of matter, chemical processes, and novel technologies resulting in cost effective commercial manufacturing processes. We develop the supply chain for APIs and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content. Chemical Engineers in AbbVie's R&D environment work in multi-functional teams to develop scalable processes and supply API for safety testing, clinical trials, and formulation development.
Chemical Engineers support API projects through all phases of development. Early in development, engineers focus on ensuring that the process can be run safely, identifying and addressing scale-up issues, and developing the final (API) process step. Later in the development process, engineers optimize the API process and lead process campaigns run in the R&D Pilot Plant. In the final stage of development, engineers transfer the optimized process to manufacturing sites, develop control strategies, prepare reports to support regulatory filings, and support process validation.
The successful candidate will play a key role in the Center of Excellence (CoE) for Isolation and Separation Technologies (CoExIST), a critical CoE within Process R&D. The mission of CoExIST is to address challenging problems in API crystallization, filtration and drying to meet the physico-chemical property attributes of all the small molecule pipeline of AbbVie through an in-depth scientific and engineering assessment of these unit operations. The members of the Center develop scientifically-sound practical processes and demonstrate them at scale. The CoExIST also leads identification and development of novel approaches and technologies to enhance efficiency in process development and commercialization. An effective collaboration with API Projects team, Solid State Chemistry and Technical Operations group is vital for the success of CoExIST. The candidate must exhibit a collaborative nature in identifying pertinent process challenges on a wide range of projects and take on a leadership role in developing and implementing solutions.
- Bachelor’s Degree or equivalent education and typically 10-14+ years of experience, Master’s Degree or equivalent education and typically 8-12+ years of experience, PhD and 0-6+ years of experience.
- Ph.D. in chemical engineering with 3+ years of relevant experience in biopharmaceuticals or allied industry preferred.
- Extensive experience in robust crystallization, filtration, and drying process development and scale-up with an emphasis on physicochemical properties control highly desired.
- Strong fundamentals in crystallization and transport phenomena.
- Demonstrated abilities to develop enabling technologies and hands on experience with pertinent process analytical technologies (PATs) is highly desired.
- Strong appetite to embrace model-based process design and development.
- The candidate is required to possess effective oral and written communication skills and abilities as a strong team player.
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.
Level and compensation will be commensurate with experience.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced