Senior Scientist I, Process Engineering

4 weeks ago

Irvine California, United States AbbVie Full time
Job Description

Process Engineering, a part of AbbVie R&D’s Development Sciences organization, is responsible for designing and developing scalable processes to make small molecule drug substances and drug products, including antibody drug conjugates (ADCs), throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products including toxins and cosmetic active ingredients (CAIs). We create valuable intellectual property through the composition of matter, chemical processes, and technologies resulting in cost-effective commercial manufacturing processes. We support the development of the supply chain for pipeline molecules and help prepare and defend CMC regulatory content.

Chemical/Bio Engineers support pipeline 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. Later in the development process, engineers optimize the drug substance and drug product processes and lead process campaigns. In the final stage of development, engineers transfer the optimized process to manufacturing sites, develop control strategy, prepare reports to support regulatory filings, and support process validation.

Role Overview

The successful neurotoxin and aesthetics engineering candidate will play a key role in the BioProcess Engineering (BPE) Center, a part of the Process Engineering function. The core deliverable of BPE is to develop robust processes to manufacture ADCs, toxins, CAIs, and biologics drug products utilizing strong engineering fundamentals.   The ideal candidate will have prior biologics process development and a passion for hands-on laboratory process development.   The candidate is also expected to lead the identification and development of novel approaches and technologies to enhance process development efficiency and commercialization. The candidate must exhibit a collaborative nature in identifying process challenges on a wide range of projects and participate in a cross-functional team to deliver specific project needs.

Key Responsibilities:

Develop robust scale up and manufacturing processes, supporting neurotoxin and aesthetics assets through all phases of development. 

Perform laboratory experiments and process modeling to support process understanding and optimization.

Address challenging problems with biochemical reactions, fermentation, separations, and/or isolations using expertise in reaction kinetics, transport phenomena, and mathematical modeling.  

Author and/or review technical documents summarizing process development efforts.

Exhibit a collaborative nature in identifying process challenges on a wide range of projects and communicate findings and recommendations effectively by maintaining strong working relationships with functions within Small Molecule CMC, Biologics CMC, and the broader CMC team. 

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