Senior Specialist, Quality Control Microbiology, Cell Therapy
Company: Bristol Myers Squibb
Posted on: August 5, 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.
This Position qualifies for a $10,000 Sign-on Bonus, $5,000 payable
within 30 days of start date and $5,000 payable following 6 months
of continuous employment. Payments are subject to a 1-year
repayment agreement from date of payment issue. Applies to external
Bristol Myers Squibb is seeking a QC Senior Specialist for QC
Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. The
QC Senior Specialist is responsible for supporting Quality Control
microbiology testing for release 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 Senior
Specialist will assist with training and assay transfer. The QC
Senior Specialist role is stationed in Devens, MA and reports to
the Manager, QC Microbiology for the Devens CTF.
* Perform compendial verification, method transfer/validation, and
routine testing of in-process, final product, and stability samples
of cell therapy drug product in accordance with applicable
procedures and cGMP requirements.
* Perform environmental and clean utilities monitoring within the
* Use scientific principles to assist with microbiological testing
methods and the proper use of laboratory equipment.
* Anticipate and troubleshoot problems.
* Train new analysts to general job duties.
* Become a qualified trainer on assigned assays and deliver
training to analysts, documenting training per procedural and cGMP
* Support document revision, project, CAPA, and
investigation/deviation related tasks.
* Perform assigned tasks within a CAPA, deviation, or project.
* May lead projects and continuous improvement efforts.
* Other duties as assigned.
* Support for QC and manufacturing operations requires shift
coverage consisting of weekdays, weekends, holidays, and during
adverse weather conditions.
* This position works the following shift schedule:
* PM Shift: Sunday to Wednesday 2 PM 12 AM
Qualifications and Education Requirements
* Bachelor s degree required, preferably in Science.
* 4+ years of relevant work experience, preferably in a regulated
* An equivalent combination of education and experience may
* Experience working in a GMP laboratory, preferably with cell
* Knowledge of aseptic technique within a laboratory
* Hands on experience with various microbiology techniques
including PCR, endotoxin and sterility testing.
* Ability to accurately and completely understand, follow,
interpret and apply Global Regulatory and cGMP requirements.
* Strong technical writing skills.
* Strong problem-solving ability/mentality, technically adept and
* Ability to represent the interests of the group on
* Strong ability to communicate effectively with peers, department
management and cross- functional peers.
* Working knowledge of LIMS and data analysis systems is highly
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 Microbiology, Cell Therapy, Healthcare , Ayer, New Hampshire
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