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

Position Summary

The Senior Scientist role is a scientific and technical expert grounded in strong laboratory capabilities, supporting the Cell Therapy product portfolio. The successful candidate will bring deep hands-on experience in bioassay with demonstrated ability to design and independently execute experiments, analyze complex data, interpret results, troubleshoot assay performance, and translate scientific findings into technically sound recommendations. The role will in part perform hands-on laboratory studies to support the optimization, transfer, validation, maintenance, and investigation of QC analytical methods. Experience working in a regulated laboratory environment is desired; however, scientific depth, experimental rigor, and analytical problem-solving are the primary qualifications for this position.

Duties/Responsibilities

• Serve as a scientific subject matter expert and steward in the lifecycle of bioassay methods used for cell therapy drug products.
• Provide bioassay expertise, including cell-based potency assays, reporter gene assays, and cell counting in support of QC lab investigations.
• Support technical investigations to identify root cause and provide corrective and preventive actions, including method remediations and experimental studies at the bench.
• Design, plan and independently execute laboratory experiments with a high degree of technical proficiency, including appropriate controls, experimental design, data analysis, interpretation, and scientifically justified conclusions.
• Collaborate with multiple cross-functional teams.
• Contribute to the development and optimization of new and existing laboratory methods and protocols.
• Present experimental findings and progress updates to immediate team.
• Support the preparation of internal technical reports and presentations as appropriate.
• Support transfer of commercial methods and method validation in compliance with global regulatory requirements.
• Implement method lifecycle and method maintenance programs to support bioassay methods in support of cell therapy drug products.
• Author, revise, and review technical documents such as test methods, SOPs, trend reports, and/or investigation reports as appropriate.
• Lead project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
• Provide support in the authoring of the analytical sections of regulatory submissions, responding to health authority questions and to function as the method validation and method transfer expert during inspections as required.
• Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives.
• Represent the function on cross-functional project teams.
• Train and mentor others on cell biology techniques, methods and procedures.
• Champion and foster a positive and successful collaborative quality culture.
• Perform other tasks as assigned.

Qualifications

• Bachelor’s degree + 8 years, Master + 4 years or PhD + 2 years in relevant scientific discipline or equivalent is required.
• Advanced degree preferred.
• 8+ years of relevant analytical experience or equivalent combination of education and experience, preferably in a regulated environment (GMP), cellular therapy, or gene therapy.
• Advanced experience and strong scientific background and expertise, encompassing various cell-therapy relevant methodologies.
• Bioassay: Cell-based bioassays such as potency, reporter gene assays, cell counting including those related to lentiviral, AAV vectors and other gene delivery platforms.
• Experience in other analytical areas such as flow cytometry and molecular biology is a plus.
• Hands-on laboratory experience and demonstrated proficiency with standard laboratory techniques relevant to the role.
• Experience in analytical method lifecycle, including method transfer, validation, and maintenance.
• Experience providing training in method execution as well as instrument operation and standardization.
• Experience in cGMP regulations and application within the Quality Control environment is a plus.
• Strong 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.
• Must possess effective time management skills, demonstrate initiative, resourcefulness, and flexibility to work independently and as part of a team.
• Strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required.
• Advance ability to communicate effectively with peers, department management, cross-functional peers.
• Ability to travel to other BMS sites or Partner sites is required.