Principal Research Scientist II Full-time

AbbVie Parenteral Product Development Science & Technology

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 setting, and willing to work across scientific disciplines to drive programs through critical milestones.
• Demonstrated scientific writing skills and strong verbal communication skills, effectively organizing and presenting scientific plans and data.

Additional Information

• 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 long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.