Hybrid Senior Scientist, Drug Product Analytical Science and Technology – Cell Therapy

at Bristol Myers Squibb

• Job title: Senior Scientist, Drug Product Analytical Science and Technology – Cell Therapy
• Job type: Full Time
• Experience level: Senior
• Salary: $115,790 - $144,241 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Seattle, United States

About the role

• Molecular biology analytical expert supporting Cellular Therapy product portfolio and QC lab investigations. Requires extensive experience in analytical methods and regulatory compliance in a cGMP environment.

Responsibilities

• Function as a molecular biology analytical expert supporting the Cellular Therapy product portfolio.
• Provide molecular biology analytical expertise in support of QC lab investigations.
• Participate in technical investigations, identifying root cause and providing corrective and preventive actions, including method remediations.
• Support transfer of commercial molecular biology methods and method validation in compliance with global regulatory requirements.
• Responsible for the stewardship of molecular biology methods in the Cell Therapy Quality organization.
• Implement method lifecycle and method maintenance programs to support molecular biology methods in support of viral vector and 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.
• 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 molecular biology 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.
• Advanced experience with various molecular biology methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms.
• 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.
• 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.