Quality Control Senior Scientist I – Biologics Analytical Research & 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.

The Biologics CMC Development team at AbbVie 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.

Job Description

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

Responsibilities:

Key responsibilities include:

• Represent the QC function on cross functional program teams.
• Collaborate with an