Senior Scientist, Vector Analytical Science And Technology (ASAT), Cell Therapy

Bristol Myers Squibb • Devens, MA

20h • Onsite

About The Position

Bristol Myers Squibb is seeking a Senior Scientist, Vector Analytical Science And Technology (ASAT) to function as an analytical expert supporting the Cellular Therapy product portfolio. The successful candidate will possess a strong foundation in the development of analytical methods for viral vector release, as well as the transfer, validation, and life-cycle management of test methods within a cGMP environment. This role involves providing expertise in viral vector analytics for QC lab investigations, supporting method transfers and validation, managing the lifecycle of analytical methods, and authoring technical documents. The position also includes leading project-related tasks, supporting regulatory submissions, partnering with development teams, and training/mentoring colleagues. Bristol Myers Squibb offers a challenging and meaningful work environment with opportunities for growth and a wide array of competitive benefits and programs designed to support employees' goals.

Requirements

• Bachelor’s degree in a relevant scientific discipline or equivalent is required.
• 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 analytical 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.
• Advanced ability to communicate effectively with peers, department management, and cross-functional peers.
• Ability to travel to other BMS sites or Partner sites is required.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• Provide viral vector analytical expertise in support of QC lab investigations, including participating in technical investigations, identifying root causes, and providing corrective and preventive actions, including method remediations.
• Support the transfer of commercial analytical methods and method validation in compliance with global regulatory requirements.
• Responsible for the stewardship of viral vector analytical methods in the Cell Therapy Quality organization.
• Implement method lifecycle and method maintenance programs to support analytical methods for viral vector drug substances.
• 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 functioning 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 analytical techniques, methods, and procedures.
• Champion and foster a positive and successful collaborative quality culture.
• Perform other tasks as assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees