Quality Control Manager Chemistry

3 weeks ago

Devens, Massachusetts, United States Bristol-Myers Squibb Full time

Transforming Patients' Lives through Science

Bristol-Myers Squibb is seeking a highly skilled Quality Control Manager Chemistry to join our team in Devens, MA. As a key member of our Quality Control team, you will be responsible for ensuring the quality and integrity of our drug substance and drug product Release & Stability samples.

Key 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.

Requirements:

  • 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 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.
  • Expertise and operational knowledge of equipment and test methods associated with the following methodologies: Spectrophotometry, Appearance testing and KarlFisher methods.
  • 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.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are committed to delivering innovative medicines that address the most pressing medical needs of our time. Our employees are empowered to apply their 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.

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