Manager, QC Operations, Bioanalytical
Company: Bristol Myers Squibb
Location: Ayer
Posted on: August 6, 2022
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Job Description:
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 in Devens, MA, is seeking a remarkable
Manager, QC Operations, Bioanalytical to join our QC team. As our
Manager, QC Operations, Bioanalytical you'll be responsible for
staff in lab area performing testing, analysis, and results
reporting of drug substance and drug product Release & Stability
samples, for effective operation of the biologics manufacturing
facilities at Devens, and our Global Biologics Network.
*This role works Monday-Friday Day Shift and is 100% onsite*
Role Responsibilities:
* Responsible for day-to-day operations of the laboratory,
including on-time testing, analysis of data and trends,
investigations, staff training, and equipment maintenance and
calibration.
* Develop and supervise staff schedules to meet workflow
demands.
* Perform data review, trending analyses and prepare protocols and
reports to support all areas of laboratory operations.
* Responsible for cGMP compliance in all aspects of assigned
laboratory operations.
* Provide technical and operational expertise for training and
developing staff, assisting in troubleshooting.
* Perform or lead investigations for out of specification
results.
* Recruit and develop a high performing team with diverse
backgrounds and talents.
* Coach direct reports to evaluate and execute continuous
improvement, develop their skill sets, and creates an environment
of continuous learning, improvement, and innovation.
* Maintain and communicate team performance metrics.
* Provide technical leadership to QC lab, serves as Subject Matter
Expert in cross-functional / cross departmental work teams, and
participates in the site team supporting and managing regulatory
inspections and findings.
* Incumbents have daily interaction with their staff and other
members of the site Quality organization.
* Supervisors may interact with any employee at any level of the
Devens Facility, with daily interactions with other departments on
site. Less frequent contact with general business functions
including human resources, EHS, Finance and BMS staff at other
locations.
Role Requirements:
* Knowledge of science generally attained through studies resulting
in a BS in physical or life sciences (e.g., Microbiology,
chemistry, biochemistry, molecular biology or related discipline)
or a combination of education and working experience.
* Minimum of 4-6 years of experience in a cGMP laboratory with 1-2
years of leadership experience. (ex. group SME, mentorship, project
lead).
* Expertise and operational knowledge of equipment and test methods
associated with the following methodologies: ELISA, qPCR and B7
Binding.
* Extensive knowledge of regulatory requirements (e.g., US, EU,
USP) and industry best practices. Prior experience supporting
regulatory agency inspections preferred.
* Previous experience with method transfers desired.
* Experience with LIMS and ELN computer applications a plus.
BMSBL, BMSBLDMA, VETERAN
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
regulations.
Keywords: Bristol Myers Squibb, Nashua , Manager, QC Operations, Bioanalytical, Executive , Ayer, New Hampshire
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