Senior Specialist, Quality Control Investigations, Cell Therapy
Company: Bristol Myers Squibb
Posted on: August 7, 2022
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
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
Support creation and review of site and department SOPs related to
Support cross functional areas to develop training curricula
related to investigations and support training to new lead
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
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
Knowledge of US and EU cGMP regulations and health authority
Demonstrated interpersonal, written and verbal communication
Ability to communicate effectively with peers, department
management and cross-functional peers.
Action-oriented and skilled in problem solving, planning and
Bachelor s degree in science, engineering, or related
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
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
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
Keywords: Bristol Myers Squibb, Nashua , Senior Specialist, Quality Control Investigations, Cell Therapy, Healthcare , Ayer, New Hampshire
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