Senior Specialist, Quality Control (Qc) Microbiology

Bristol Myers Squibb Devens , MA 01434

Posted 2 months ago

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

This Position qualifies for a $10,000 Sign-on Bonus, $5,000 payable within 30 days of start date and $5,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.

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.

Job Responsibilities

  • 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:

  • AM Shift: 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.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and 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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.


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Senior Specialist, Quality Control (Qc) Microbiology

Bristol Myers Squibb