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Job Details


Bristol Myers Squibb

Sr. Manager, QC Release & Stability - Bioseparations (R1560364-en-us)

Technology

Development Manager

Yearly

No

Devens, Massachusetts, United States

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.

Job Summary

Reporting to the Associate Director, QC Release & Stability, the Sr. Manager Bioseparations role will be responsible for leading a team of SMEs/analysts responsible for the technical transfer, troubleshooting, and technical documentation related to bioseparations related assays. The Sr. Manager, Bioseparations, may also perform other duties and participate on a variety of network teams (technical/ strategic) in support of business processes/ improvements.

Qualifications

  • Knowledge of science generally attained through studies resulting in a BS in physical or life sciences (e.g., chemistry, biochemistry, molecular biology or related discipline) or its equivalent is required.
  • Minimum of 8 years of experience in a cGMP laboratory area with 3+ years of experience with management of laboratory personnel required preferred.
  • Expertise and operational knowledge of equipment and test methods within the Bioseparations lab (HPLC/UPLC, glycan, gel electrophoresis, and Capillary electrophoresis methodologies).
  • Extensive knowledge of regulatory requirements (e.g., US, EU, USP) and industry best practices. Prior experience supporting regulatory agency inspections preferred.
  • Strong general laboratory and organizational skills, effective communication skills, both oral and written.
  • Demonstrated leadership, interpersonal, communication, and motivational skills with strong problem solving and analytical thinking skills. High attention to detail.
  • Experience in building and growing an organization into a high-performance team. Demonstrated capability of influencing in matrix environment.
  • Experience with method validation and technical transfer preferred.
  • Proficient in common computer software applications. Experience with Infinity, DCA, LIMS, and ELN a plus.

Responsibilities

  • Manage QC staff and/or supervisors performing testing, analysis, and results reporting of Release & Stability samples, for effective operation of the biologics manufacturing facilities at Devens, and/or the Global Biologics Network.
  • Accountable for daily operations of the QC lab(s), including on-time testing, analysis of data and trends, investigations, staff training, and equipment maintenance and calibration. Manage staff schedules to meet workflow demands.
  • Accountable for support of Analytical method tech transfer/validation for new molecules
  • Perform data review, trending analyses and preparation of protocols and reports to support areas of laboratory operations.
  • Accountable for cGMP compliance in all aspects of assigned laboratory operations.
  • Provide technical and operational expertise for training and developing staff, assisting in troubleshooting. Supervise investigations for out of specification results.
  • Recruit and develop a high performing team with diverse backgrounds and talents. Create an environment of continuous learning, improvement, and innovation. Coach team in execution of continuous improvement and self-development.
  • Establish, maintain, and communicate team performance metrics.
  • Provide strategic leadership to the assigned QC laboratories, 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.

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.

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