Scientist, QC Microbiology, Cell Therapy

About the role

Subject matter expert supporting method transfer, validation, and routine testing of in-process, final product, and stability samples. Perform data review, verification, complex troubleshooting, and method training. Own projects, document revisions, deviations, investigations, CAPA, and continuous improvement efforts.

Responsibilities

• Serve as subject matter expert for method transfer, verification, validation, and routine testing of in-process, final product, and stability samples.
• Perform review of testing data (e.g., data packets, final lot file, COA review).
• Anticipate and perform complex troubleshooting and problem solving independently.
• Perform data verification, data review, and review of GMP documentation for multiple methods (general and complex) and/or products.
• Own project, CAPA, and deviation/investigation-related tasks and/or continuous improvement efforts.
• Represent the department in regulatory inspections (internal and external audits).
• Train and mentor others on multiple QC test methods, processes, and procedures.
• Cross-train on multiple complex microbiology methods and/or multiple products.
• Author and review/revise technical documents such as test methods, SOPs, specifications, trend reports, and/or sample plans.
• Perform other tasks as assigned.

Requirements

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
• 6+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience with microbiological techniques.
• Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability, technically adept, and logical.
• Ability to communicate effectively with peers, department management, and cross-functional peers about task status, roadblocks, and needs.
• Advanced ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced knowledge of LIMS, ELN, and laboratory data analysis systems preferred.
• Strong mentoring, coaching, influencing, negotiating, and personnel interaction skills.

Pay

Devens - MA - US: $99,380 - $120,428 starting compensation range for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.

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:
  • 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.
  • 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 Year’s Day.

All global employees (full and part-time) who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Schedule

Occupancy structure determines work location:

• Site-essential roles: Require 100% of shifts onsite at your assigned facility.
• Site-by-design roles: May be eligible for a hybrid work model with at least 50% onsite at your assigned facility. Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.
• Field-based and remote-by-design roles: Ability to physically travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed is an essential job function.