Principal Research Scientist II, Parenteral PDS&T Analytical Development
Listed on 2026-01-12
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Healthcare
Clinical Research, Data Scientist, Medical Science
Principal Research Scientist II, Parenteral PDS&T Analytical Development
Company Description Abb Vie'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 Abb Vie, please visit us at Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.
Job Description 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, 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 Abb Vie's pipeline of innovative medicines. The Analytical Development group is responsible for programs that are transitioning from development stage to optimization and commercialization. We develop and implement commercial analytical control strategies including final method optimization and validation, ensuring all analytical methods are fit for use in commercial QC laboratories.
Key deliverables also include product control strategies informed by analytical data and method understanding; comprehensive data packages that drive product and process understanding; stability studies to establish commercial product dating; and approvable marketing application submission content.
We are looking for a highly motivated person who can serve as the Analytical Lead for late stage biologics parenteral products. The candidate will develop strategies and manage timelines for the analytical deliverables of their given development programs. The candidate will also interface with key Analytical stakeholders across organizations as well as cross‑functional CMC business partners in the characterization of biologics compounds and provide key data for regulatory submissions, including IND/IMPD amendments and BLA filings.
Key Responsibilities- 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) or Masters Degree (14+ years) or Bachelors Degree (16+ years) in a 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)…
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