Quality Control Senior Scientist - Biologics Analytical Research & 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.

The Biologics CMC Development team at Abb Vie in the Bay Area has a long and rich history of biologics development. Now located in a new, state‑of‑the‑art facility in South San Francisco, the team leverages its comprehensive end‑to‑end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapeutics, such as bi‑specifics and novel modalities, to human clinical studies and eventual licensure.

Abb Vie's Biologics CMC Analytical Research and Development Group in South San Francisco is seeking an experienced and highly motivated Senior Scientist I to join our Quality Control team focused on early stage (first in human through Phase 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.

Additionally, you will create and/or review change records and quality event records in support of GxP activities.

• Represent the QC function on cross‑functional program teams.
• Collaborate with analytical leads to achieve release and stability program deliverables.
• Author quality documents and regulatory submissions to enable regulatory submissions and clinical supply.
• Perform data verification.
• Trending of stability data using JMP or other statistical software to support retest dating.
• Prepare and review quality control documents, including certificates of analysis, method validation reports, reference standard qualification reports, release & stability protocols, and stability reports.
• Initiate and review change records in collaboration with Technical and Quality SMEs and stakeholders.
• Coordinate closely with document authors, owners, stakeholders and approvers in South San Francisco and other Abb Vie sites to initiate and complete document workflows within target timelines.
• Ensure compliance with SOPs, standards, and requirements.
• Provide support during internal and external audits and inspections.

Serve as a subject matter expert for GxP quality system document management activities including: document formatting, document processing in the electronic document management system, document categorization/numbering nomenclature, and approval.

• Bachelor's Degree or equivalent education with typically 10+ years of relevant experience, or Master's Degree or equivalent education with typically 8+ years of relevant experience.
• General understanding of analytical methods typically employed for release and stability testing of protein therapeutics (monoclonal antibodies and antibody drug conjugates).
• Experience evaluating and trending GMP stability data for drug substance and drug product shelf life assignment.
• Proficient in data analysis tools (e.g. JMP) and LIMS systems.
• Experience authoring quality control related change records and exception reports.
• Solid understanding of test methods used for release and stability analysis of antibody‑based therapeutics as acquired through hands‑on lab experience.
• Strong knowledge of GxP…