QC Operations Associate Scientist

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.

Position: QC Associate Scientist

Location: Devens, MA

Hours: Monday- Friday 8:00am-4:00pm (On-site)

Roles and Responsibilities

• This is a direct support function to the QC Operations Microbiology and Facilities/Utilities groups, providing both technical and operational oversight to the lab and driving solutions in support of department or site deliverables.

• Perform routine GMP data review and or authorization of Microbiological assays in a cGMP compliant environment.

• Subject matter expert in one or more methodologies associated with In-Process, Incoming materials and Environmental Control in both the clinical and commercial space.

• Execute troubleshooting techniques independently, help support junior analysts including training for multiple methodologies within the lab. May perform routine testing to support team in times of elevated testing volumes.

• Investigate out of specification results, lead low or medium risk deviations, and perform impact assessments and periodic reviews of department procedures and related changes. Execute routine cGMP compliance assessments against Compendial updates and in relation to all aspects of assigned laboratory operations.

• Author/lead revisions to SOPs for managerial review and approval. Lead transfer strategies, author associated protocols and reports as required.

• Provide technical leadership to the assigned QC laboratories. Serve as Subject Matter Expert in cross-functional and matrix working teams and participate in site team supporting and managing of regulatory inspections and findings.

• Participate in Bioburden and Endotoxin qualification studies in support of new products coming through the Clinical facility. May represent QC within site or network project teams.

• Evaluate and drive continuous improvements to standard methods, procedures, and processes. Support data trending analysis and author all quarterly and bi-annual EM and Utility reports.

• Routinely demonstrate leadership, independent problem solving, critical and analytical thinking skills.

Knowledge, Skills & Behaviors

• Knowledge of science generally attained through studies resulting in a B.S., in biological sciences, a related discipline, or its equivalent.

• A minimum of 6 years’ experience in a GMP Biologics, QC Laboratory, or related cGLP / cGMP regulated laboratory.

• Expertise and knowledge of regulatory requirements, and industry best practices utilized within the QC Operations laboratory. Prior experience supporting regulatory agency inspections preferred.

• Proficiency in microbiological laboratory techniques, regulatory standards, and in applying cGMP regulations and Compendial testing requirements.

• Excellent organizational skills with proficiency with common computer software applications (such as email, MS office, etc) and lab based computer applications (LIMS, LES, Infinity, etc).

• Strong attention to detail with demonstrated ability to work independently as well as a part of a team or matrix setting to complete assignments within defined time constraints.

• Proven aptitude for driving solutions with appropriate sense of urgency. This role requires continual interaction with members of his/ her team as well as other sub-teams within QC, in order to exchange information regarding matrix roles and responsibilities, coordinating resources, and procedural actions within established timelines.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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