Senior Scientist, Drug Product Analytical Science, Cell Therapy

Role Overview

• 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.

Requirements

• 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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short
• and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
• Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.