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 Development, Technical Operations, Quality, Regulatory, Clinical Development, Supply Chain, and external development and manufacturing partners. The position requires deep CMC expertise, with particular strength in cell and gene therapy and/or cell-based technologies. Familiarity with advanced or emerging therapeutic modalities and manufacturing platforms is a plus and may help the candidate contribute to programs where technologies, processes, and development expectations are evolving.
- 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, and 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, and business priorities.
- Serves as a subject matter expert for cell and gene therapy and cell-based therapeutic platforms; familiarity with AAV or other viral vectors, baculovirus-based expression systems, insect cell platforms, oligonucleotides, nucleic acid-based therapeutics, or other emerging modalities is a plus.
- Provides expert technical input and scientific oversight for work conducted with external development and manufacturing partners, including CDMOs, CROs, technology providers, and strategic collaborators; supports technical scope definition, deliverable review, issue investigation, and risk mitigation.
- Participates as a senior CMC expert on cross-functional program teams and partners with Process Development, Analytical Development, Quality, Regulatory CMC, Manufacturing, Supply Chain, Engineering, Clinical Development, and other functions to ensure technical considerations are evaluated and communicated clearly.
- Strengthens organizational capability by sharing platform knowledge, advancing scientific standards and technical practices, evaluating external innovation, mentoring colleagues, and promoting scientific rigor, collaboration, accountability, and continuous improvement.
Education:
Advanced degree in a relevant scientific or engineering discipline preferred; Bachelor?s degree with significant relevant industry experience will be considered.
Related Experience:
- 8+ years of relevant industry experience in CMC, process engineering, pharmaceutical development, biotechnology, chemical manufacturing, process development, manufacturing, or a related technical discipline.
- 5+ years of experience in the cell and gene therapy field preferred, including experience serving as a senior scientific or technical expert for complex biologic, cell therapy, gene therapy, or other advanced therapeutic programs.
- Direct experience with cell and gene therapy and/or cell-based therapeutic platforms; familiarity with AAV or other viral vector development and manufacturing is a plus.
- Demonstrated experience in process improvement development and execution, including the ability to identify technical gaps, recommend improvements, and support implementation in an operations or development context.
- Demonstrated experience organizing, developing, and deploying best-practice frameworks, processes, tools, and templates in alignment with enterprise standards.
- 5+ years of experience working within a global matrix organization, with involvement in cross-functional, multicultural, and international teams.
- Familiarity with baculovirus-based expression systems, insect cell platforms, oligonucleotides, nucleic acid-based therapeutics, recombinant proteins, or other emerging modalities is a plus.
- Demonstrated experience working with external development and manufacturing organizations, including CDMO selection, technical due diligence, technology transfer, governance, and issue resolution.
- Strong understanding of CMC principles across product and process development, analytical strategy, control strategy, manufacturing, technology transfer, stability, regulatory requirements, and lifecycle management.
- Demonstrated ability to influence technical direction through subject matter expertise, evidence-based recommendations, and effective collaboration in a global, matrixed pharmaceutical or biotechnology environment.
The expected base salary range for this position at hiring is $179,000 - $212,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
