Senior Specialist, QC Microbiology, 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
Bristol Myers Squibb is seeking a QC Senior Specialist for QC Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. The QC Senior Specialist is responsible for supporting Quality Control microbiology testing for release of clinical and commercial cell therapy drug product. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, the QC Senior Specialist will assist with training and assay transfer. The QC Senior Specialist role is stationed in Devens, MA and reports to the Manager, QC Microbiology for the Devens CTF.
- Perform compendial verification, method transfer/validation, and routine testing of in-process, final product, and stability samples of cell therapy drug product in accordance with applicable procedures and cGMP requirements.
- Perform environmental and clean utilities monitoring within the manufacturing environment.
- Use scientific principles to assist with microbiological testing methods and the proper use of laboratory equipment.
- Anticipate and troubleshoot problems.
- Train new analysts to general job duties.
- Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.
- Support document revision, project, CAPA, and investigation/deviation related tasks.
- Perform assigned tasks within a CAPA, deviation, or project.
- May lead projects and continuous improvement efforts.
- Other duties as assigned.
- Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions.
- This position works the following shift schedule:
- Wednesday to Saturday 6 AM – 4 PM
Qualifications and Education Requirements
- Bachelor’s degree required, preferably in Science.
- 4+ years of relevant work experience, preferably in a regulated environment.
- An equivalent combination of education and experience may substitute.
- Experience working in a GMP laboratory, preferably with cell therapy products.
- Knowledge of aseptic technique within a laboratory environment.
- Hands on experience with various microbiology techniques including PCR, endotoxin and sterility testing.
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Strong technical writing skills.
- Strong problem-solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the group on cross-functional teams.
- Strong ability to communicate effectively with peers, department management and cross- functional peers.
- Working knowledge of LIMS and data analysis systems is highly desirable.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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