Bristol-Myers Squibb Company

Supervisor, QC Chemistry

Location
Devens, MA, United States
Posted
May 23, 2019
Ref
R1515008
Required Education
Bachelors Degree
Position Type
Full time
Supervises assigned Quality Control Operations staff performing chemistry and biochemistry testing, analysis, and reporting of final bulk product and, stability samples for the effective operations of a biologics manufacturing facility.

• Develops and manages staff schedules to meet workflow demands
• Performs data review, supports trending analyses, and protocol/ report review
in QC Chemistry.
• Develops and implements standard methods and procedures for technical transfer of
methods, inspection, testing, analysis of data and trends, investigations, staff training,
and equipment maintenance and calibration.
• Ensures cGMP compliance in all aspects of QC Operations laboratories.
• Recruits and develops a high performing team with diverse backgrounds and talents.
• Coaches and counsels team members to develop their skill sets and create an
environment of continuous learning, improvement, and innovation.
• Maintains and communicates performance metrics for her/his team, setting and
maintaining high expectations for team performance.
• Provides technical leadership to QC Operations, 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.
• Investigates out-of-specification results and writes/supervises investigation reports.

Qualifications:
• BS/BA in science - Microbiology, biology, chemistry, biochemistry, a related discipline - or
its equivalent is required.
• A minimum of 6 years experience in quality control.
• Experience in overseeing QC testing is required.
• Prior supervisory experience preferred.
• Strong background in chemistry/biochemistry methods for biologics methodology,
specifically protein concentration, Karl Fisher, and appearance/particles methods
• Extensive knowledge of US and EU cGMP regulations USP, regulatory requirements and
industry best practices.
• Demonstrated leadership, interpersonal, communication, motivation skills with strong
problem solving and analytical thinking skills.
• Knowledge of applicable business systems including: LIMS, SmartLab, Trackwise and
Investigates out-of-specification results and writes investigation reports.
• Experience with regulatory agency (FDA, EMEA, TGA) inspections preferred.