Senior Specialist, Quality Control Investigations, Cell Therapy (R1552914-en-us)
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.
Bristol Myers Squibb is seeking a Senior Specialist, QC Investigations for the Quality Control organization at the Cell Therapy Facility (CTF) in Devens, MA. This role is responsible for conducting QC high impact deviations, laboratory investigations, and CAPAs. This includes the ability to interface with multiple groups, the ability to independently perform tasks, execute root cause analysis, and document findings. Additionally, the QC Investigations Senior Specialist will support developing, tracking, and continuously improving QC investigation metrics. This role is stationed in Devens, MA and reports to the Senior Manager, QC Investigations.
• Subject matter expert leading QC high impact deviations, laboratory investigations, and CAPAs. Author reports for QC deviations, investigations and CAPAs.
• Work with QC method SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations and CAPAs.
• Support creation and review of site and department SOPs related to investigations.
• Support cross functional areas to develop training curricula related to investigations and support training to new lead investigators.
• Contribute to and support the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
• Apply critical thinking skills during the investigations and process improvements.
• Communicate effectively with management and cross functional teams such as Manufacturing, QC Operations and QA. Present investigation findings at Quality governance forums.
Qualifications & Education Requirements
• Experience in laboratory or biomanufacturing investigations and root cause analysis techniques.
• Knowledge of cell therapy analytical and microbiological testing is highly desirable.
• Knowledge of US and EU cGMP regulations and health authority inspections.
• Demonstrated interpersonal, written and verbal communication skills.
• Ability to communicate effectively with peers, department management and cross-functional peers.
• Action-oriented and skilled in problem solving, planning and organizing.
• Bachelor’s degree in science, engineering, or related discipline.
• 4+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required. An equivalent combination of education and experience may substitute.
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.
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.
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