Senior Scientist, Process Development II

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

The ABC 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

Responsibilities

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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.
• 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.
• 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.
• Lead analytical sub-teams, translating development goals into practical analytical tasks, and providing expert advice to peers and senior management.
• Design and implement work packages essential for achieving development and commercial objectives.
• 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.
• Analyze and identify data trends in key analytical release and stability assays, showcasing scientific excellence in the analytical characterization of biologics.
• Draft and review Module 3 content for both early and late-stage programs as needed.
• Mentor peers in project management and the creation of analytical strategies.
• Communicate project strategy, key issues, and risks to relevant teams, escalating risks and promoting resolution within and across functional areas.

Qualifications

• 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.
• 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.
• 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.
• Familiarity with industry USP/ICH guidance for the development, qualification, and validation of analytical methods.
• 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.
• Ability to work effectively across functions, anticipating and addressing overall program development needs.
• Open to collaborative efforts, valuing diverse perspectives and managing relationships effectively to enhance decision-making.
• A self-motivated, meticulous individual who thrives in a fast-paced team environment.
• Exhibits creative and innovative thinking to tackle complex challenges and advocates for new technologies to fulfill project objectives.
• Quickly comprehends and adapts to new situations, demonstrating agility when necessary.

Additional Information

Applicable only to applicants