Senior Principal Scientist - Remote

CSL•Waltham, MA

3d•$179,000 - $212,000•Remote

About The Position

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. It requires deep CMC expertise, particularly in cell and gene therapy and/or cell-based technologies. Familiarity with advanced or emerging therapeutic modalities and manufacturing platforms is a plus. The role applies scientific and technical expertise to CMC strategy discussions covering process and analytical development, characterization, manufacturing, technology transfer, stability, control strategy, and lifecycle management. It develops data-driven technical recommendations and fit-for-purpose approaches that balance scientific rationale, regulatory expectations, quality requirements, supply needs, timelines, and business priorities. The scientist provides technical input and oversight for work with external development and manufacturing partners, including CDMOs, CROs, technology providers, and strategic collaborators. The role also contributes as a senior CMC expert on cross-functional program teams and 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.

Requirements

8+ years of relevant industry experience in CMC, process engineering, pharmaceutical development, biotechnology, chemical manufacturing, process development, manufacturing, or a related technical discipline.
Direct experience with cell and gene therapy and/or cell-based therapeutic platforms.
Demonstrated experience in process improvement development and execution, including identifying technical gaps, recommending improvements, and supporting implementation in an operations or development context.
Demonstrated experience organizing, developing, and deploying best-practice frameworks, processes, tools, and templates aligned with enterprise standards.
5+ years of experience working within a global matrix organization, with involvement in cross-functional, multicultural, and international teams.
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.

Nice To Haves

Advanced degree in a relevant scientific or engineering discipline.
5+ years of experience in the cell and gene therapy field, including experience serving as a senior scientific or technical expert for complex biologic, cell therapy, gene therapy, or other advanced therapeutic programs.
Familiarity with AAV or other viral vector development and manufacturing.
Familiarity with baculovirus-based expression systems, insect cell platforms, oligonucleotides, nucleic acid-based therapeutics, recombinant proteins, or other emerging modalities.

Responsibilities

Apply deep scientific and technical expertise to CMC strategy discussions for innovative biologics, covering process development, analytical development, characterization, manufacturing, technology transfer, stability, control strategy, and lifecycle management.
Develop data-driven technical recommendations and fit-for-purpose approaches appropriate to each program's stage and complexity, balancing scientific, regulatory, quality, supply, timeline, and business considerations.
Serve as a subject matter expert for cell and gene therapy and cell-based therapeutic platforms.
Provide technical input and scientific oversight for external development and manufacturing partners, including defining technical scope, reviewing deliverables, investigating issues, and mitigating risks.
Participate as a senior CMC expert on cross-functional program teams and work with relevant functions to ensure technical considerations are evaluated and communicated clearly.
Share platform knowledge, advance scientific standards and technical practices, evaluate external innovation, mentor colleagues, and promote scientific rigor, collaboration, accountability, and continuous improvement.