[Hiring] Senior Principal Scientist @CSL

Role Description

The Principal Scientist, CMC serves as a senior scientific subject matter expert for Chemistry, Manufacturing and Controls activities supporting innovative biologics. The role provides expert technical assessment, scientific guidance, and risk-based recommendations to program teams working across various functions.

• Applies deep scientific and technical expertise to CMC strategy discussions for innovative biologics, including:
  • Process development
  • Analytical development
  • Characterization
  • Manufacturing
  • Technology transfer
  • Stability
  • Control strategy
  • Lifecycle management
• Develops data-driven technical recommendations and fit-for-purpose approaches appropriate to the stage and complexity of each program, balancing:
  • Scientific rationale
  • Regulatory expectations
  • Quality requirements
  • Supply needs
  • Timelines
  • Business priorities
• Serves as a subject matter expert for cell and gene therapy and cell-based therapeutic platforms.
• Provides expert technical input and scientific oversight for work conducted with external development and manufacturing partners.
• Participates as a senior CMC expert on cross-functional program teams.
• Strengthens organizational capability by sharing platform knowledge and promoting scientific rigor.

Qualifications

• Advanced degree in a relevant scientific or engineering discipline preferred; Bachelor’s degree with significant relevant industry experience will be considered.
• 8+ years of relevant industry experience in CMC, process engineering, pharmaceutical development, biotechnology, or related technical discipline.
• 5+ years of experience in the cell and gene therapy field preferred.
• Direct experience with cell and gene therapy and/or cell-based therapeutic platforms.
• Demonstrated experience in process improvement development and execution.
• 5+ years of experience working within a global matrix organization.
• Familiarity with baculovirus-based expression systems, insect cell platforms, oligonucleotides, nucleic acid-based therapeutics, or other emerging modalities is a plus.
• Demonstrated experience working with external development and manufacturing organizations.
• Strong understanding of CMC principles across product and process development.
• Demonstrated ability to influence technical direction through subject matter expertise.

Requirements

• Experience serving as a senior scientific or technical expert for complex biologic, cell therapy, gene therapy, or other advanced therapeutic programs.
• Ability to identify technical gaps, recommend improvements, and support implementation in an operations or development context.
• Experience organizing, developing, and deploying best-practice frameworks, processes, tools, and templates in alignment with enterprise standards.

Benefits

• Expected base salary range for this position at hiring is $179,000 - $212,000.
• Total compensation may also include incentive compensation and equity.

Company Description

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in various therapeutic areas.

• Operates one of the world’s largest plasma collection networks, CSL Plasma.
• Parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.
• Delivers lifesaving therapies to people in more than 100 countries.