Bristol Myers Squibb QC STAT Team Lead in Devens, Massachusetts
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 STAT Team Lead
Bristol-Myers Squibb is seeking an experienced quality control professional for the position of QC STAT Team PM Shift Lead to work a 12 hour (36/48) rotating shift (5PM to 5AM). Responsibilities include but are not limited to:
Lead a night shift team of analysts. This individual will have continual interaction with members of his/her team as well as other teams throughout the facility in order to exchange information regarding testing completed, in process and planned. The team lead will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions.
Work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. As essential personnel, when on shift, the applicant will be required to work holidays, during inclement weather, and occasional overtime to meet project timelines when required.
Observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions.
Perform routine assays such as UV-VIS Spectrometry, TOC, and more complex assays including various HPLC methodologies, as well as lead equipment troubleshooting activities and investigate out of specification results. Individual may support method transfer testing.
Perform data review of in-process and Bulk Drug Substance samples in a cGMP compliant environment.
Train less experienced analysts on basic and complex test methods.
Write and revise SOPs for managerial review and approval as well as write technical reports (for example Investigations or Qualification) and perform data analysis and trending for both method transfers and investigations.
Knowledge of science generally attained through studies resulting in a BS/MS Degree or equivalent, preferably in Chemistry or Biological Sciences.
Minimum of 6 years’ experience in Biologics QC laboratory or related biopharmaceutical cGMP lab.
Strong chemistry background is preferred with proficiency and/or mastery of one or more of the following test methods: Sialic Acid, A280, TOC, Titer, AKTA purification.
Thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility. Can effectively interact with inspectors during lab tours.
Experience in interpreting and applying cGMPs, USP/compendia, regulatory requirements and industry best practices.
Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
Proficient in lab software applications (e.g., LIMS, ELN (LES/SmartLab), Empower).
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 email@example.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.
Company: Bristol Myers Squibb
Req Number: R1560558
Updated: 2022-11-28 05:15:17.516 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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