Lead Principal Scientist, External Drug Product Development

University of Georgia- FACS

South San Francisco (CA)

Sur place

USD 190 000 - 235 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Comprehensive benefits
Long-term incentives
Paid time off

Résumé du poste

AbbVie in South San Francisco, CA, seeks a Principle Scientist I for the Drug Product Development group. This on-site role leads external CDMO interactions, guiding formulation and process development for biologics, and ensuring compliant, efficient outsourcing.

You will partner with project leads, operations, and management to align strategy, timelines, and deliverables. The role requires extensive experience in formulation, lyophilization, and analytical characterization, plus strong

Qualifications

  • BS or equivalent education in chemical engineering, pharmaceutical sciences, material science, analytical sciences, or related field.
  • Typically 14+ years for PhD, 12+ for MS, or 6+ for PhD-related industry experience.

Responsabilités

  • Serve as primary external liaison between ABA DPD and CDMOs for drug product development.
  • Lead formulation and process development activities and technology transfer.
  • Oversee CDMO execution of studies, development plans, and data packages.
  • Review study designs and communicate recommendations to CDMO and internal teams.
  • Ensure readiness for CDMO governance and facilitate issue resolution.
  • Coordinate communication between CDMOs and internal stakeholders.
  • Maintain organized project documentation and knowledge management.
  • May support internal programs as drug product lead on CMC teams.

Connaissances

Formulation principles
Drug product degradation
Lyophilization processing
DOE (Design of Experiments)
CDMO oversight
Analytical techniques
Protein characterization
Project leadership
Stakeholder management
Communication skills

Formation

BS/MS/PhD in relevant field

Outils

JMP
Design Expert

Description du poste

AbbVie in South San Francisco, CA, seeks a Principle Scientist I for the Drug Product Development group. This on-site role leads external CDMO interactions, guiding formulation and process development for biologics, and ensuring compliant, efficient outsourcing.

You will partner with project leads, operations, and management to align strategy, timelines, and deliverables. The role requires extensive experience in formulation, lyophilization, and analytical characterization, plus strong

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