Principal Research Scientist I, Cmc Purification Development

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