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 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 associate 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

• Support development, optimization, and scale-up of purification processes through lab-based and -scale up lab operation activities
• Support transfer of purification processes to GMP manufacturing for clinical material production
• Execute routine purification development operations from harvest to UF/DF following established protocols, independently after appropriate training, and generate reliable and consistent results
• Analyze and critique experimental results, document and promptly communicate significant deviations or unexpected results
• Prepare small to large (500L) batches of buffer solutions following batch record recipe
• Support scale up lab activities including preparation and execution
• Perform routine analytical measurements using HPLC and UV-vis instrumentation
• Accurately record experimental observations and results at the time of execution; maintain complete, traceable data sets and batch records, including instrument files and analytical results, in electronic notebooks, databases, and Excel files in accordance with established documentation procedures and timelines
• Perform general lab maintenance including cleanliness, equipment maintenance and maintaining inventory
• Follow applicable laboratory and scale up plant safety procedures and standard operating procedures (SOPs), complete required training before performing assigned activities
• Collaborate within the team in order to follow best practices and meet project goals
• Participate in the evaluation of novel, advanced bioprocess technologies that are in line with the group’s strategy 
• Learn and understand new experimental techniques
• Must be comfortable with physical activities of constant standing, walking, sitting and occasionally lifting up to 50 Ibs
• Author technical reports and presentations including preparing verbal updates and presentations at group meetings.