Senior Principal Scientist

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as a senior scientific expert in Chemistry, Manufacturing, and Controls (CMC) activities supporting cutting-edge biologics.

• Offer expert technical evaluations, scientific guidance, and risk-based suggestions to program teams.

• Utilize scientific and technical knowledge in CMC strategy discussions, encompassing process development, analytical development, characterization, manufacturing, technology transfer, stability, control strategy, and lifecycle management.

• Formulate data-driven technical recommendations and tailored approaches for various programs.

• Function as a subject matter authority on cell and gene therapy and cell-based therapeutic platforms.

• Provide technical insights and scientific supervision for external development and manufacturing partners.

• Assist in defining technical scope, reviewing deliverables, investigating issues, and mitigating risks.

• Engage as a senior CMC expert within cross-functional program teams.

• Collaborate with Process Development, Analytical Development, Quality, Regulatory CMC, Manufacturing, Supply Chain, Engineering, Clinical Development, and other departments.

• Disseminate platform expertise, enhance scientific standards and technical practices, assess external innovations, mentor peers, and advocate for continuous improvement.

⛳️ Requirements

• An advanced degree in a pertinent scientific or engineering field is preferred; a Bachelor's degree with substantial relevant industry experience will also be considered.

• Over 8 years of relevant industry experience in CMC, process engineering, pharmaceutical development, biotechnology, chemical manufacturing, process development, manufacturing, or a related technical area.

• More than 5 years of experience in the cell and gene therapy sector is preferred.

• Direct experience with cell and gene therapy and/or cell-based therapeutic platforms.

• Knowledge of AAV or other viral vector development and manufacturing is advantageous.

• Proven experience in developing and executing process improvements.

• Capability to identify technical deficiencies, suggest enhancements, and assist in implementation.

• Established experience in organizing, developing, and deploying best-practice frameworks, processes, tools, and templates.

• Over 5 years of experience within a global matrix organization.

• Experience working with 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 collaborating 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.

• Proven ability to influence technical direction through subject matter expertise, evidence-based recommendations, and effective collaboration in a global, matrixed pharmaceutical or biotechnology setting.

🏝️ Benefits

• Incentive compensation.

• Equity.

• Inclusion and Belonging culture.

• Reasonable accommodation for applicants with disabilities.