Associate Scientist II, Process 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.

Job Description

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 therapies, such as bi-specifics and novel modalities, to human clinical studies and eventual licensure. This Senior Scientist I role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs.

As one of CMC purification development scientists, you will work in the CMC purification team to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. This position is an onsite role in a lab-based function. To be successful, candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face interactions between scientists.

Responsibilities include:

• Support development, optimization, and scale-up of purification processes through lab-based and pilot plant operation activities
• Support transfer of purification processes to GMP manufacturing for clinical material production
• Execute routine purification development operations from harvest to UF/DF operations competently and independently, and generate reliable and consistent results
• Analyze and critique experimental results, noting significant deviations
• Prepare small to large (500L) batches of buffer solutions following batch re