Principal Research Scientist II

## Company Description **About AbbVie** 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](http://www.abbvie.com/). Follow @abbvie on [LinkedIn,](https://www.linkedin.com/company/abbvie/) [Facebook](https://www.facebook.com/AbbVieGlobal/), [Instagram](https://www.instagram.com/abbvie/), [X](https://twitter.com/abbvie) and [YouTube.](https://www.youtube.com/user/AbbVie) ## Job Description **Job Description** AbbVie Parenteral Product Development Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral products. Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from clinical proof of concept through commercial product launch. We are a world-class team of scientists and leaders driving the advancement of industry-leading analytical capabilities and AbbVie's pipeline of innovative medicines. Careers in AbbVie Parenteral PDS&T provide opportunities to work with global and cross-functional teams to develop innovative products and drive exceptional science. The Analytical Development group is responsible for programs that are transitioning from development stage to optimization and commercialization. We lead final method development, optimization, and validation, ensuring all analytical methods are fit for use in commercial QC laboratories. Additionally, we collaborate with the Drug Product Process Development groups to design and execute comprehensive studies that drive product and process understanding and support marketing application submission content. We are looking for a highly motivated person who can oversee process analytics within the Analytical Development team. **Key Responsibilities** The Process Analytics Lead (PA Lead) works closely with the Drug Product team to coordinate analytical testing support for drug product process development studies. The PA Lead would develop study designs and testing plans in collaboration with the Drug Product Team and coordinate testing within the Analytical Team. For any PA work that is outsourced, the PA lead would work with the outsourcing team to identify the appropriate third party lab, determine the scope of work to be outsourced, and coordinate test method transfer (as needed). The PA Lead would help coordinate sample shipments both coming into the analytical lab and shipping from the analytical lab. They would also review, assess, and interpret data relative to the samples generated for testing performed both internally and externally. The PA lead would be a key member of analytical subteams. They would oversee activities, protocol generation, and communication of timelines and data generated. ## Qualifications - PhD (8+ years), Master’s Degree (14+ years), or Bachelor’s Degree (16+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous laboratory experience. - Practical experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis is preferred. - Practical experience with troubleshooting methods, examining data wholistically, and guiding and advising scientists through study execution. - Solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development, is preferred. - Ability to multitask and work within timelines, delivering results in a team-oriented settin…