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Bristol Myers Squibb

Associate Scientist - QC Bioseparations

Science and Research

Scientist

No

Devens, Massachusetts, United States

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us

Position: Associate Scientist - QC Bioseparations

Location: Devens, MA

Position Summary:

The Quality Control Bioseparations Associate Scientist will support the lab supervisor with the day-to-day release and stability testing within the bioseparations labs. This role will lead or support the method technical transfer and/or validation activities for a cGMP biologics commercial and clinical manufacturing analytical laboratory and will act as a Subject Matter Expert (SME) for analytical methods such as HPLC, UPLC, Capillary Electrophoresis (CE), iCIEF, and SDS-PAGE, providing technical support for the lab analyst. The role will require flexibility, high attention to detail, and a quality-driven mindset. This opportunity will allow the QC Bioseparations Associate Scientist to become a member of diverse project teams across a global, matrix organization.

Responsibilities:

  • Author and review technical documents such as technical transfer protocols and reports.

  • Support multi-site method transfer and validation projects.

  • Troubleshoot QC analytical methods and equipment.

  • Review and approve QC analytical lab data.

  • Execute release and stability testing in the QC lab, as needed.

  • Develop training approach for new methods.

  • Develop and implement innovative, continuous improvement techniques.

  • Ability to recognize anomalous trends or results.

  • Ability to quickly adapt to change and adjust tasks in order to reach shared business goals or timelines.

  • Front room FDA/Inspectional experience on systems, QEs, method transfers etc.

  • Performs investigations for OOS, data analysis for method transfers and process investigations, assists in troubleshooting lab procedures and taking required corrective actions

  • Provide the technical expertise in support of method transfer/ validation activities / release and stability testing.

  • Ability to work across intra and inter functional departments to achieve alignment of company objectives.

  • Reviews or writes technical reports and perform data analysis and trending for both method transfers and investigations.

  • Recognize and troubleshoot analytical method excursion. Provide guidance for equipment troubleshooting as needed.

  • Trains less experienced analysts on basic and complex test methods.

  • Peer review/ approval of lab data generated as a part of method transfer/ validation activities or for ongoing release and stability testing.

Qualifications:

  • BS / MS or equivalent, preferably in Analytical Chemistry or related discipline.

  • Minimum of 4 years (MS) / 6 years (BS) relevant experience in scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab.

  • Front room FDA/Inspectional experience on systems, QEs, method transfers etc.

  • Knowledge in QC analytical equipment qualifications (IQOQPQ) and decommissioning.

  • Front room regulatory agency (FDA, EMA) inspection involvement.

  • Knowledge in cGMP regulations as referenced in The Code of Federal Regulations.

  • Provide technical support for CAPAs, lab investigations, out of trend alerts, and OOS results for QC analytical methods.

  • Experience using equipment such as HPLC, UPLC, Capillary Electrophoresis (CE), Charged Aerosol Detector (CD).

#Veteran

#BMSBLDMA

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.