Quality Control Scientist II (Fully Onsite Position)

About AbbVie 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical development of AbbVie's pipeline of innovative therapeutic biologic products. We are a world-class team of scientists and leaders united by a shared mission to advance industry-leading analytical capabilities and meaningfully contribute to the advancement of AbbVie’s pipeline of innovative medicines.  The Biologics ARD team at the AbbVie Bay Area site in South San Francisco has a long and rich history of biologics development. Located in a state-of-the-art facility housing end-to-end CMC development capabilities, the team works collaboratively to advance novel biologic therapeutics – including multi-specifics, ADCs, antibodies, and novel modalities – into first-in-human clinical development and through to clinical proof of concept. Careers in AbbVie Biologics ARD provide unique opportunities to work with cross-functional and global teams to drive exceptional science and innovative product development strategies.

Summary We are seeking an experienced and highly motivated Scientist II to join our Quality Control team focused on early stage (first in human through Ph 2 clinical) development. The Quality Control team is responsible for a wide range of Quality Control GxP activities, including change management, document management, coordination of outsourced release and stability testing, shelf-life evaluation, preparation of Certificates of Analysis and coordination of the exception/quality event process. In this role, you will represent the QC function on one or more program teams, with responsibility for authoring quality documents and regulatory submission sections. You will collaborate with Technical and Quality SMEs to achieve QC deliverables for release of GMP drug substance and drug product batches to enable clinical supply, as well as manage shelf-life assignment for clinical batches.

Represent the QC function on cross functional program teams. Collaborate with analytical leads to achieve release and stability program deliverables. Author quality documents and IND/IMPD sections to enable regulatory submissions and clinical supply. Evaluate and trend stability data using JMP or other statistical software to support retest dating and shelf life assignments. Prepare and review/verify quality control documents, including certificates of analysis, reference standard qualification reports, release & stability protocols, data packages and stability reports. Initiate and review change records in collaboration with Technical and Quality SMEs and stakeholders. Provide support during internal and external audits and inspections. Serve as a subject matter expert for GxP quality system document management activities and coordinate closely with document authors, owners, stakeholders and approvers to initiate and complete document workflows within target timelines. Ensure compliance with SOPs, standards, and requirements.

BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience. Must have a minimum of two years hands-on experience: Lab experience with methods commonly employed for release and stability testing of antibody therapeutics. Evaluating and