Senior Scientist II, CMC BioProcess Purification Development

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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 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 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 include:

Development, optimize, and scale-up purification processes for biologics candidates to support early and late stage development

Demonstrate the ability to resolve key project or process hurdles by effectively utilizing available information, technical expertise, cross-functional collaboration and scientific literature

Transfer processes to GMP manufacturing for clinical material production

Work with contract labs and carry out viral clearance studies

Conceive and evaluate novel, advanced bioprocess technologies and workflow methodologies that are in line with the group and company's strategy

Publish research in peer-reviewed journals and present work at scientific conferences

Proactively seek out new information in the literature or through internal/external collaborations and incorporate the knowledge to address individual program needs as well as into platform project strategy

Seize opportunities to pursue project relevant leads that are in line with the group's strategy

Maintain a high level of productivity in the lab by individual contributions and through mentorship or direct supervision

Author technical publications, reports, presentations, and regulatory filings

Work efficiently and collaboratively toward setting program specific functional and cross-functional project timelines and goals

Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GxP compliance, where applicable

Participate on cross-functional project teams

May mentor/supervise a team; guide and evaluate the performance of those individuals; accountable for the effective performance of the team/individuals

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