Principal Research Scientist I, CMC Purification Development

Full Job Description

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 Principal 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 group leaders, you will apply your strong expertise in CMC purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. You will be responsible for all aspects of CMC purification program deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams.  

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 cross-functional interactions between scientists.

Responsibilities: 

Effectively function as a principal investigator, generating original technical ideas and development strategies  

Lead development, optimization, and scale-up of purification processes for biologics candidates to support early and late-stage development  

Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific advances and respond with appropriate new strategies . Conceive and evaluate novel advanced separation technologies and techniques  

Lead purification strategy for biologic candidates and take accountability for project deliverables  

Independently responsible for project science within his/her area of expertise on one or more project teams.

Represent purification development team and actively influence development strategy on cross-functional CMC teams  

Make significant contributions to project team through lab-based activities  

Proactively seek out new tools, techniques, and strategies to implement into individual pro grams (s) as well as the overall downstream platform  

Be hands-on and execute lab and pilot scale operations to meet project deliverables  

Transfer processes to GMP manufacturing

 

Work with contract labs and carry out viral clearance studies  

 

Write technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals and presenting work at scientific conferences  

Work efficiently, collaboratively, and cross-functionally toward project timelines and goals   

Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals