Manager, QC Operations, Bioanalytical

Company: Bristol Myers Squibb
Location: Ayer
Posted on: August 6, 2022

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