Senior Specialist, QC Analytical, Cell Therapy

Working with Us
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 rich in diversity. 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.

Our Quality Assurance and Compliance organization is pivotal in upholding quality standards within aseptic manufacturing, with core competencies in Microbiology and Chemistry. Our oversight extends across the entire product lifecycle, encompassing manufacturing, batch release, investigations, customer feedback management, document control, Quality Control testing, and diligent audits. Our team harnesses cutting-edge analytical and biologic test methods, leveraging state-of-the-art instrumentation and streamlined digital processes to meticulously affirm control.

The QC Senior Specialist, Assay Trainer will support the QC Training Program. They will be responsible for performing On the Job Training for QC Assays and material release procedures (Immunoassay, PCR, Flow Cytometry, Raw Material, and/or Microbiological) and additional lab tasks. They will be responsible for developing and maintaining the related training materials. Additionally, they will assist with projects such as technology transfers, method transfers, training related deviations, CAPAs, and change controls. Good Communication and organizational skills are a requirement. Knowledge of GxP Regulations and how they apply to complex lab workflows is recommended. This position is 100% on-site in Bothell, WA.

Shift Available:

• Monday - Friday, Onsite Day Shift

Responsibilities:

• Perform On-The-Job Training (OJT) and Instructor Lead Courses (ILC) for QC Associates

• Revise and develop training materials to support the QC Training Program

• Support QC department by creating and running reports in the Learning Management System (LMS)

• Assist in verification of training status for all QC Associates

• Assist with quality systems for training related deviations, CAPAs, and Change Controls

• Participate in internal and external audit reviews of QC Training

• Track and schedule training

• Assist in troubleshooting technical assay issues and data analysis

• Act as liaison between lab staff and global analytical, science and technology / analytical development as subject matter expert

Knowledge & Skills:

• Working knowledge of QC laboratory operations

• Experience in delivering training for Flow Cytometry, Microbiology, PCR, and/or Immunoassay

• Ability to interact and communicate effectively with other departments to meet project milestones and goals

• Computer proficiency as well as strong scientific and organizational skills.

• Experience with deviations, CAPAs, and change controls

• Demonstrated success working in a high-performing, business results-driven environment

• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others

• Ability to maintain flexible intellect and adjust to a dynamic work environment

Basic Requirements:

• BS in Science or equivalent (preferably in Science)

• Expert experience in one or more of the assay testing within a laboratory (Immunoassays, Microbiology, PCR, and/or Flow Cytometry) with a minimum of 4 years hands-on testing experience

• A minimum of 1 year experience as a trainer