Senior Scientist

Bristol Myers SquibbSummit, NJ
5d$109,050 - $132,139Onsite

About The Position

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. Position Summary The Senior Scientist responsible for supporting routine testing of samples in Quality Control for the Bristol Myers Squibb (BMS) CAR-T Manufacturing facility located in Summit, NJ in accordance with BMS policies, standards, procedures and Global cGMPs. This position requires working independently and within project teams under the guidance of an experienced leader. As the subject matter expert (SME) of the commercial methods, the Senior Scientist will be responsible for QC lab method support, method transfer and validation, leading projects, troubleshooting, and training.

Requirements

  • Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.
  • Demonstrated advanced technical writing skills.
  • Advanced problem-solving ability/mentality, technically adept and logical.
  • Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple complex projects.
  • Advanced ability to communicate and collaborate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs, locally and globally.
  • Demonstrated strategic thinking.
  • Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.
  • Bachelor’s degree required, preferably in Science.
  • 8+ years of relevant microbiological testing, including 2+ years of QC experience, or an equivalent combination of education and experience.
  • Advanced experience with various microbiology techniques and principals including contamination control, environmental monitoring, and method characterization, verification/validation, and transfer.

Nice To Haves

  • Advanced degree preferred.

Responsibilities

  • Subject matter expert supporting method transfer/verification/ validation and routine testing of in-process, final product, and stability samples.
  • Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for non-routine complex issues.
  • Perform data verification, data review and review of GMP documentation for general and complex methods.
  • Subject matter expert for training others on test methods and complex processes.
  • Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
  • Represent the department in product review boards and regulatory inspections (internal and external audits).
  • May author responses to regulatory requests.
  • Lead project, CAPA and deviation/ investigation and/ or continuous improvement efforts.
  • Train and mentor others on multiple complex QC test methods, processes 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.
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