Principal Research Scientist II, Parenteral PDS&T Analytical Development

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. 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 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. 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 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. 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 short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. 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. 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