CASY-MSCCN Jobs

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Process Engineering, a part of AbbVie R&D’s Small Molecule CMC Development 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 robust and 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 candidate will play a key role in the Process Engineering function. The core deliverable of Process Engineering is to develop robust processes to manufacture small molecule Active Pharmaceutical Ingredients (API), ADCs, toxins, CAIs, and biologics drug products utilizing strong engineering fundamentals. Process Engineering also leads the development of commercial-ready isolation and purification strategies for both small and large molecule compounds. The ideal candidate will have a passion for hands-on laboratory process development and a proven track record in research and 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 teams to deliver against specific project needs.

Key Responsibilities:

• Develop robust scale up and manufacturing processes, supporting small and/or large molecule assets through all phases of development.

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

• Address challenging problems with reactions, separations, and/or isolations using expertise in reaction kinetics, thermodynamics, crystallization fundamentals, 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.

Qualifications

Qualifications:

• BS, MS, or PhD in Chemical Engineering and 10+ (BS), 8+ (MS), or 0+ (PhD) years of relevant industrial experience.

• 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.

• The candidate is required to possess effective oral and written communication skills and be a strong team player.

Preferred:

• Working knowledge of analytical techniques such as HPLC, FTIR, Raman, and microscopy.

• Prior crystallization, isolation, or purification experience (highly preferred!!)

• Experience with laboratory experimentation and process scale-up.

• Experience with Process Analytical Technologies (PAT).

• 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.

Additional Information

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.