Quality Control Manager Chemistry

4 weeks ago

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

Transforming Lives through Science

Bristol-Myers Squibb is seeking a talented Quality Control Manager Chemistry to join our team. As a key member of our Quality Control team, you will be responsible for ensuring the quality of our drug substances and drug products.

Key Responsibilities:

  • Lead the 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.
  • Ensure 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 create an environment of continuous learning, improvement, and innovation.
  • Maintain and communicate team performance metrics.
  • Provide technical leadership to QC lab, serve as Subject Matter Expert in cross-functional / cross-departmental work teams, and participate 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 discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Our employees are united by a shared passion to transform patients' lives through science.

Equal Employment Opportunity

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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