Quality Control Manager
3 weeks ago
Bristol-Myers Squibb is seeking a highly skilled and experienced Manager, QC Operations, Bioanalytical to join our team in Devens, MA. As a key member of our Quality Control team, you will be responsible for leading the day-to-day operations of the laboratory, ensuring the effective operation of the biologics manufacturing facilities at Devens and our Global Biologics Network.
Key Responsibilities:- Lead the laboratory team in performing testing, analysis, and results reporting of drug substance and drug product Release & Stability samples.
- 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 the QC lab, serve as a Subject Matter Expert in cross-functional/cross-departmental work teams, and participate in site teams supporting and managing regulatory inspections and findings.
- Bachelor's degree in a physical or life science (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 Spectrophotometry, Appearance testing, and Karl-Fisher 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.
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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