Senior Principal Scientist, Drug Product Analytical Science and Technology (ASAT), Cell Therapy

About the role

This technical leadership role is a highly experienced subject matter expert in molecular biology analytical methods and related areas, responsible for leading the design, execution, and interpretation of complex, high impact scientific programs. This role will manage a team responsible for method optimization, transfer, and validation in support of Cell Therapy analytical portfolio.

Responsibilities

• Lead and manage a team responsible for molecular biology method technical investigation, method optimization/remediations, method transfer and method validation in compliance with regulatory requirements.
• Perform and/or direct team on hands-on laboratory work in support of commercial QC analytical methods investigation, remediation, and/or optimization.
• Connects lab-level science to portfolio strategy, pipeline value, and organizational mission.
• Critically evaluate experimental data across the team, identifying scientific risks and opportunities, and recommending course corrections as appropriate.
• Integrate scientific findings across multiple experiments and datasets to generate meaningful insights and advance program hypotheses.
• Make high-impact scientific and strategic decisions under conditions of uncertainty; balances scientific ambition with pragmatic risk management.
• Represent the department in product review boards, regulatory inspections (internal and external audits).
• Own and author relevant analytical sections of regulatory submission and responses to health authority questions and requests.
• Implement method lifecycle and method maintenance programs to support methods in support of viral vector and cell therapy drug products.
• Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives.
• Represent ASAT interest on cross functional/ cross-site teams and communicate and collaborate effectively.
• Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for non-routine complex issues.
• Hire, mentor, and develop exceptional ASAT personnel.

Qualifications

• Strong scientific background and expertise with various molecular methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms.
• Demonstrated advanced technical writing skills.
• Highly advanced strategic thinking and problem-solving ability/mentality, technically adept and logical.
• Demonstrated ability to work independently in a fast-paced matrix environment, meet deadlines, and prioritize work from multiple projects.
• Track record of scientific productivity as evidenced by publications, presentations, or equivalent internal contributions.
• Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally.
• Advanced technical skills, including execution, and interpretation of complex, high-impact scientific, multi-dimensional data in support of commercial QC analytical methods.
• Expert at writing formal reports/documents and technical presentations in support of investigations and regulatory submission.
• Able to translate complex science for diverse audiences.
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.
• Able to travel to support projects as needed.

Education/Experience/Licenses/Certifications

• Bachelor’s/Master’s degree preferably in (bioanalytical) science. Advanced degree preferred.
• 10+ years of relevant experience in regulated cellular therapy or gene therapy, or an equivalent combination of education and experience.
• Expert scientific knowledge with a broad range of molecular techniques including lentiviral, AAV vectors and other gene delivery platforms.
• Experience in bioanalytical techniques (cell-based assays, ELISA, flow cytometry) is a plus.
• Deep expertise with the characterization, validation, and transfer of bioanalytical methods lifecycle.
• Experience in cGMP regulations and application within the Quality Control environment.
• Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, cell therapies, vaccines and/or biological products.