Scientist, QC Microbiology, Cell Therapy

Bristol Myers Squibb • Devens, MA

2d • Onsite

About The Position

Bristol Myers Squibb is seeking a Subject Matter Expert to support method transfer/validation and routine testing of in-process, final product, and stability samples. This role involves performing data review/verification, complex troubleshooting, and method training. The individual will own projects, document revisions, deviations/investigations/CAPA, and continuous improvement efforts. Bristol Myers Squibb offers a supportive culture and competitive benefits, aiming to transform patients' lives through science.

Requirements

• Bachelor’s degree or equivalent required, preferably in science.
• 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/mentality, 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.
• Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.

Nice To Haves

• Advanced degree preferred.
• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.

Responsibilities

• Subject matter expert supporting 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.
• May represent the department in regulatory inspections (internal and external audits).
• Train and mentor others on multiple QC test methods, processes and procedures.
• Cross trained 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 as appropriate.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior