Senior Scientist II, CMC BioProcess Purification Development Specialist

3 days ago


South San Francisco California, United States AbbVie Full time
About the Role

The Biologics CMC Development team at AbbVie is seeking a highly experienced Senior Scientist II to lead the development of robust, phase-appropriate processes for drug substance GMP production. As a key member of the team, you will be responsible for all aspects of CMC purification program deliverables and help drive drug substance purification development strategy through program lead assignments in cross-functional CMC teams.

Key Responsibilities
  • Develop, 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.
About AbbVie

AbbVie is a global biopharmaceutical company that is committed to discovering and delivering innovative solutions to patients with serious diseases. Our Biologics CMC Development team is a key part of this effort, working to advance complex biologic therapies through all phases of development and licensure.



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