Senior Principal Scientist

CSL Plasma•Waltham, MA

1d•$179,000 - $212,000

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 across Development, Technical Operations, Quality, Regulatory, Clinical Development, Supply Chain, and external development and manufacturing partners. Deep CMC expertise is required, 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 across process and analytical development, characterization, manufacturing, technology transfer, stability, control strategy, and lifecycle management. It develops data-driven recommendations and fit-for-purpose approaches that account for program stage and complexity, scientific rationale, regulatory and quality expectations, supply needs, timelines, and business priorities. As a subject matter expert for cell and gene therapy and cell-based therapeutic platforms, the position provides technical input and scientific oversight for work with external development and manufacturing partners, including CDMOs, CROs, technology providers, and strategic collaborators. This includes supporting technical scope definition, deliverable review, issue investigation, and risk mitigation. The role participates as a senior CMC expert on cross-functional program teams and works with technical, quality, regulatory, manufacturing, supply chain, engineering, and clinical functions to ensure technical considerations are evaluated and communicated clearly. The position also 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

At least 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.
Strong understanding of CMC principles across product and process development, analytical strategy, control strategy, manufacturing, technology transfer, stability, regulatory requirements, and lifecycle management.
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 in alignment with enterprise standards.
At least 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.
Demonstrated ability to influence technical direction through subject matter expertise, evidence-based recommendations, and effective collaboration in a global, matrixed pharmaceutical or biotechnology environment.
An advanced degree in a relevant scientific or engineering discipline is preferred; a bachelor's degree with significant relevant industry experience will be considered.

Nice To Haves

At least 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

Provide expert technical assessment, scientific guidance, and risk-based recommendations for CMC activities supporting innovative biologics.
Contribute to CMC strategy discussions 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 that reflect program stage, complexity, regulatory and quality expectations, supply needs, timelines, and business priorities.
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 support for technical scope definition, deliverable review, issue investigation, and risk mitigation.
Participate as a senior CMC expert on cross-functional program teams and collaborate with internal functions to evaluate and communicate technical considerations.
Strengthen organizational capability by sharing platform knowledge, advancing scientific standards and technical practices, evaluating external innovation, mentoring colleagues, and promoting continuous improvement.
Identify technical gaps, recommend process improvements, and support their implementation in development or operations contexts.
Organize, develop, and deploy best-practice frameworks, processes, tools, and templates aligned with enterprise standards.
Support external partner activities including CDMO selection, technical due diligence, technology transfer, governance, and issue resolution.