QC Senior Specialist
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.
QC Senior Specialist
BMS in Devens, MA is seeking an experienced QC Senior Specialist. The QC Senior Specialist is responsible for supporting Quality Control Release and Stability Bioanalytical testing of 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 may assist with assay transfer activities. The QC Senior Specialist role is stationed in Devens, MA and reports to the Manager, QC Bioanalytical for the Devens Biologics.
Performs routine testing and data review of stability and batch release samples in a cGMP compliant environment.
Performs routine assays such as ELISA, qPCR and B7 binding.
Performs broad range of troubleshooting techniques and leads such within area of expertise.
Write and revise SOPs for managerial review and approval.
Train less experienced analysts on complex test methods.
Train on additional methodologies, and provide support to a broader spectrum of testing responsibilities
May Lead/ support investigations through data gathering or interview process
Support method transfers in the Bioanalytical team as a primary analyst in the tech transfer process
Lead Opex related projects in terms of visual management system and metrics tracking
Support lab in audit readiness activities and data integrity initiatives
Knowledge of science generally attained through studies resulting in a BS degree, preferably in Chemistry, Molecular Biology, or related discipline.
A minimum of 4 years of experience in a Biologics QC laboratory in the testing environment.
Experience in analytical test methods such as ELISA, qPCR or micro testing.
Knowledge of lab software applications (e.g., LIMS, (LES/SmartLab)) preferred.
High attention to detail with strong general laboratory and good organizational skills.
Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
Ability to interpret and apply cGMPs, regulatory requirements and industry best practices.
Demonstrates problem solving and analytical thinking skills.
Experience working on visual management scheduling tools, 5S and op-ex initiatives is highly preferred.
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 firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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