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 (ADC). We create valuable intellectual property through composition of matter, chemical processes and technologies resulting in cost effective commercial manufacturing processes. We develop the supply chain for APIs, prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
Chemical Engineers within AbbVie's Process R&D organization work in multi-functional teams to develop scalable processes and supply active pharmaceutical ingredient (API) for safety testing, clinical trials, and formulation development. Early in development, engineers focus on ensuring the process can be run safely, identifying, and addressing major 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 and support process validation.
The Senior Scientist will play a key role in the Cross-functional Modeling Forum (CMF), a broader CMC center of excellence for modeling and simulation. The mission of this Center is to address challenging problems in CMC areas by working collaboratively and cross-functionally by developing appropriate in-silico tools to enable right at first pass scale-up and technology transfer of various drug substance and drug product processes.
We are seeking an engineering modeling specialist to identify and develop novel modeling approaches to enhance efficiency of biopharmaceutical process understanding, development and optimization. Ideal candidates should possess an advanced degree in chemical engineering with a demonstrated experience in the application of data science-based modeling to biopharmaceutical drug development.
- Proactively seek opportunities to come up with out of box and innovative solutions to cater challenging business problems through creative application of modeling and simulation
- Build experimentally verified mathematical models for a variety of chemical/biological API/drug product processes and associated process equipment.
- Provide deeper understanding of process/product performance using appropriate modeling and simulation tools
- Harness power of mathematical modeling to come up with innovative process and/or equipment designs in a strongly collaborative environment involving chemists/ pharmacists/ biologists/ engineers
- Exhibit a strong motivation to implement and advance data science-based modeling across AbbVie
- Learn and venture into new areas of business interest
- Play a strong team player in a cross functional collaborative environment thriving for world class excellence
- Demonstrate excellent communication skills and specifically
- illustrate strong oral and written technical communications
- seamlessly present modeling solutions to multifunctional teams
- educate and train colleagues on various modeling tools and techniques
- BS, MS, or PhD in Chemical Engineering with the research experience in data science-based modeling as applied to bio-chemical processes and/or drug development. (Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary).
- Exposure to the modeling of medical devices and/or PKPD/PBPK modeling would be a plus.
- Desirable to have exposure to open-source machine learning (ML), natural language processing (NLP) and computer vision (CV) packages with the demonstrated ability to build and integrate user defined subroutines and custom modeling functions.
- Exposure to computer programming languages like Django, Python, Bash and C will be a plus.
- 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 ideas of others, nurtures innovation and manages innovation to reality.
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