Principal Research Scientist II, Parenteral PDS&T Analytical Development

Principal Research Scientist II, Parenteral PDS&T Analytical Development

Abb Vie Parenteral Product Development Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of Abb Vie's parenteral products. Our scope includes Abb Vie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, spanning 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 Abb Vie's pipeline of innovative medicines. Careers in Abb Vie Parenteral PDS&T provide opportunities to work with global and cross‑functional teams to develop innovative products and drive exceptional science.

$/yr - $/yr

• Develop analytical strategies and communicate with PDS&T business partners for experimental execution in support of stability studies, comparability studies, and extended characterization of biologics products (e.g., mAbs, ADCs, bispecifics).
• Interpret and identify data trends in key analytical release and stability assays.
• Develop robust analytical control strategies including commercial specifications.
• Author regulatory filings (including IND and BLA filings) and address questions from health authorities.
• Proactively advise and share knowledge/expert opinions with peers and senior management; mentor peers in project management and development of analytical strategies.
• Collaborate with third‑party laboratories and manufacturers for outsourced programs to ensure CMC timelines are met.
• Author and/or review key regulatory documents, technical memos, and reports.
• Encourage ideas for continuous improvement activities and initiatives within work group.

• 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 work experience (6+ years) in a pharmaceutical laboratory setting.
• Preferred candidate should have experience in project management/leadership of analytical development activities for biologic compounds (mAbs, antibody drug conjugates, and/or fusion proteins).
• Experience in analytical technologies (HPLC, UV‑Vis, compendial tests, and KF). Experience in bioanalytical techniques including SEC, CEX, CE‑SDS, icIEF, peptide mapping, bioassay, ELISA, subvisible particle analysis for parenteral drug products preferred.
• Experienced in laboratory systems (LIMS, CDS, ELN) preferred.
• Statistical knowledge and experience are preferred, e.g., capability analysis and design of experiments (DOE) methodologies.
• Solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development, is preferred.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and strong verbal communication skills.

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.

Mid‑Senior level

Full‑time

Other

Pharmaceutical Manufacturing and Biotechnology Research

Abb Vie 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.