Specialist, QC Analytical, A2 Shift, Cell Therapy

Company: Bristol Myers Squibb
Location: Ayer
Posted on: August 5, 2022

Job Description:

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.

Job Summary

Bristol Myers Squibb is seeking a QC Specialist for QC Analytical at the Cell Therapy Facility (CTF) in Devens, MA. The QC Specialist is responsible for supporting Quality Control bioanalytical testing for method validation, critical reagent qualification, in-process, release, and stability testing 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 Specialist may assist with assay transfer. The QC Specialist role is stationed in Devens, MA and reports to the Manager, QC Analytical for the Devens CTF.

This position works the following shift schedule: PM Shift: Sunday to Wednesday 2 PM 12 AM.

Job Responsibilities

* Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
* Use scientific principles to assist with analytical testing methods and the proper use of laboratory equipment.
* Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
* Review all data in accordance with applicable procedures and cGMP requirements.
* Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
* Train new analysts to general job duties.
* Support document revision, project, CAPA, and investigation/deviation related tasks.
* Perform assigned tasks within a CAPA, deviation, or project.
* Participate in projects and continuous improvement efforts.
* Perform other tasks as assigned.
* Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions.

Qualifications and Education Requirements

* Bachelor s degree required, preferably in Science. Advanced degree preferred.
* 2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
* Hands on experience with various bioanalytical techniques (cell-based assays, flow cytometry, ELISA, qPCR).

* 1+ years of experience in multi-parameter (> 8-color) flow cytometry execution and technical support. Immunology experience is preferred.
* Experience working with polychromatic flow cytometry panels and flow cytometry data analysis (FCS Express, FlowJo) is a plus.

* Scientific knowledge in the characterization, validation and transfer of bioanalytical methods preferred.
* Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
* Technical writing skills.
* Problem-solving ability/mentality, technically adept and logical.
* Ability to work in a high-paced team environment, meet deadlines, and prioritize work.
* Ability to communicate effectively with peers, department management and cross-functional peers.
* Knowledge of LIMS and laboratory data analysis systems preferred.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

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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 ...@bms.com (mailto:...@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.

Keywords: Bristol Myers Squibb, Nashua , Specialist, QC Analytical, A2 Shift, Cell Therapy, Healthcare , Ayer, New Hampshire