Senior Scientist, Drug Product Analytical Sciences (ASAT), Cell Therapy

Position Summary

The Scientist role is a technical expert supporting the Cellular Therapy product portfolio. Successful candidates will have a strong foundation in designing and conducting experiments at the laboratory bench, analyzing data, and interpreting results in bioassay, flow cytometry or molecular biology methods, or a combination thereof. This role will perform hands-on laboratory experiments in support of QC analytical methods.

Duties/Responsibilities

• Provide bioassay, flow cytometry and/or molecular biology analytical expertise in support of QC lab investigations. This encompasses supporting technical investigations to identify root cause and provide corrective and preventive actions, including method remediations and experimental studies at the bench.
• In accordance with established protocols and research objectives, design, plan and independently execute experimental work with a high degree of technical proficiency, contribute to data analysis and documentation, and collaborate within 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.
• Responsible for the stewardship of bioassay, flow cytometry and/or molecular methods in the Cell Therapy Quality organization.
• Implement method lifecycle and method maintenance programs to support bioassay, flow cytometry and/or molecular biology 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/molecular biology/ flow cytometry techniques, methods and procedures.
• Champion and foster a positive and successful collaborative quality culture.
• Perform other tasks as assigned.

Qualifications

• Bachelor’s degree 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.
• Advance 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. Flow Cytometry: Range of instrument platforms and standardization, multiparameter applications, antibody titration. Molecular Biology: Molecular methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms.
• 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.
• 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.