<p>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.</p> <p>Job Description</p> <p>The PDS&T Analytical Development team is seeking an analytical project lead to develop a comprehensive analytical strategy for mAbs, ADCs, bi-specifics, fusion proteins, AAVs etc. This position calls for a strategic thinker with a robust technical background in analytics, coupled with the ability to lead cross-functional teams, manage intricate projects, and communicate effectively with stakeholders.</p> <ul> <li>Represent Analytical Development in AbbVie's CMC teams, providing support for both early and late-stage assets. Serve as the key contact for stakeholders, ensuring balanced expectations between PDST and Analytical fields. </li><li>Formulate and convey analytical strategies to Analytical PDS&T functions and CMC business partners, guiding experimental execution for product analytical control strategies, method development/validation/transfer, and studies on release, stability, comparability, and extended characterization of biologics. </li><li>Manage a team by providing guidance and support to achieve goals. Foster a positive environment, encourage development, address performance issues, and promote collaboration and communication. </li><li>Lead analytical sub-teams, translating development goals into practical analytical tasks, and providing expert advice to peers and senior management. </li><li>Design and implement work packages essential for achieving development and commercial objectives. </li><li>Proficient in utilizing a broad range of analytical techniques to support DS process development, characterization, validation studies, product liability assessments, and analysis of impurities and variants. </li><li>Analyze and identify data trends in key analytical release and stability assays, showcasing scientific excellence in the analytical characterization of biologics. </li><li>Draft and review Module 3 content for both early and late-stage programs as needed. </li><li>Mentor peers in project management and the creation of analytical strategies. </li><li>Communicate project strategy, key issues, and risks to relevant teams, escalating risks and promoting resolution within and across functional areas. </li></ul> <p>Qualifications</p> <ul> <li>BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline. </li><li>Experience in managing and leading analytical development activities for biologic compounds, such as mAbs, bispecifics, antibody-drug conjugates, and/or fusion proteins, along with a strong understanding of CMC analytical and regulatory requirements. </li><li>Proficient in protein HPLC (e.g., SEC, IEX, RPLC), capillary electrophoresis (CE, icIEF), and other separation techniques for protein analysis. Experience in mass spectrometry (intact/reduced LCMS, peptide mapping) and ELISA is a good plus. </li><li>Familiarity with industry USP/ICH guidance for the development, qualification, and validation of analytical methods. </li><li>Hands-on experience in authoring, reviewing, submitting, and responding to regulatory requests related to IND, IMPD, BLA/MAA. Skilled in technical writing, including drafting method validation protocols/reports and comparability protocols/reports. </li><li>Ability to work effectively across functions, anticipating and addressing overall program development needs. </li><li>Open to collaborative efforts, valuing diverse perspectives and managing relationships effectively to enhance decision-making. </li><li>A self-motivated, meticulous individual who thrives in a fast-paced team environment. </li><li>Exhibits creative and innovative thinking to tackle complex challenges and advocates for new technologies to fulfill project objectives. </li><li>Quickly comprehends and adapts to new situations, demonstrating agility when necessary. </li></ul> <p>Additional Information</p> <p>Applicable only to applicants</p>