Associate QC Scientist Team Lead

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Responsibilities:

Oversee day-to-day operations in the QC Microbiology laboratory, providing both operational and technical oversight to the lab for effective operation of the biological manufacturing facilities at Devens and the Global Biologics Network.

Perform routine data review and authorization of utility, raw material, in-process, BDS, and stability samples in a cGMP compliant environment.

Subject matter expert and trainer in microbiological methods including bioburden and endotoxin testing.

Execute troubleshooting techniques independently and support junior analyst.

Investigate out-of-specification results and lead low risk deviations. Execute routine cGMP compliance in all aspects of assigned laboratory operations.

Author/lead revisions to SOPs for managerial review and approval. Author protocols/reports as required.

Provide technical leadership. Serve as Subject Mater Expert in cross-functional/cross-departmental work teams, and participate in the support and management of regulatory inspections and findings.

Lead continuous improvement efforts. Evaluate and suggest improvements to standard methods/procedures/processes. Support data trending, analysis and reporting of team KPIs.

Represent QC on site or network project teams.

Author WFI and clean steam utility trend reports.

Perform routine testing to support team in times of elevated testing volumes.

Qualifications:

Knowledge of science generally attained through studies resulting in a B.S., in biological sciences, a related discipline, or its equivalent is preferred.

Minimum 6 years of experience in a cGMP microbiology laboratory.

Expertise and operational knowledge of QC microbiology equipment and test methods.

Extensive knowledge of regulatory requirements (e.g., US, EU, USP) and industry best practices. Prior experience supporting regulatory agency inspections is preferred.

Strong general laboratory and organizational skills, effective communication skills, both written and oral.

Strong technical writing skills.

Excellent aseptic technique.

Proficient in common computer software applications. Experience with LIMS and LES computer applications is a plus.

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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com