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.
The successful neurotoxin and aesthetics engineering candidate will play a key role in the Center for BioProcess Engineering (BPE), 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 experience 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, participate in a cross-functional team to deliver specific project needs, and take on a leadership role in developing and implementing solutions.
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, 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.
Ensure compliance with Federal Regulations for key documentation and sample inventory.
BS, MS, or PhD in Chemical/Bio Engineering or a related field and 14+ (BS), 12+ (MS), or 6+ (PhD) years of relevant industrial experience.
Ph.D. candidates with pertinent research exposure are also encouraged to apply.
Job level will be commensurate with academic and/or industrial work experience.
Candidates are expected to have a strong background in chemical engineering and the proven ability to demonstrate their skills in this field.
This position requires the individual to work with and in areas requiring select agents access (biosafety level 2 and 3 laboratories).
The candidate is required to possess effective oral and written communication skills and be a strong team player.
Biologics process development experience, particularly designing and scaling up of bioreactor and purification processes for protein therapeutics.
Working knowledge of analytical techniques such as HPLC, FTIR, Raman, and microscopy.
Experience with laboratory experimentation and process scale-up.
Familiarity with operation of chemical/biochemical process equipment and systems.
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 enables innovation to reality.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.