QC CHEMISTRY LEAD at Devens

Job Description

Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts. The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site. Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.

*Trains staff, monitors and performs testing of raw materials, in-process, release, and stability of the Bulk Drug Substance in a cGMP environment.

*Develops methods and procedures, to ensure compliance with corporate policies and procedures. Reviews data obtained for compliance to specifications and reports abnormalities.

*Provides technical and operational expertise for training and developing staff, assisting in troubleshooting and performing investigations for out of specification results.

*Develops and maintain expertise in one or more test methods.

*Performs investigations for out of specification results.

*Writes technical reports, and reviews and revises standard operating procedures as needed.

*Performs data analysis and trending for method transfers and process investigations.

*Assists in troubleshooting laboratory equipment and procedures, taking required corrective action.

*Position is Sunday to Wednesday approximately 7 AM-5 PM.

*Overtime and remote support is also required at times.

Job Requirements

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

*Minimum of 4 years of experience as a senior analyst in Biologics QC lab or experience in a related biopharmaceutical GLP or GMP laboratory.

*An HPLC Lead will need strong technical experience in HPLC methods for proteins, including, SEC, carbohydrate testing and peptide map.

*Experience with Biacore, ELISA or other protein based test methods is a plus.

*Previous experience with method transfer desired.

*Experience with LIMS and Smart lab computer applications a plus.

*Proficient in common computer software applications.

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

*Strong attention to detail.

*Direct daily interaction with all staff and management of Quality Control Chemistry. Regular interaction with all departments within the facility as required in the conduct of assigned work. Occasional interaction with Quality employees from other sites for methods transfer and training.

*Oversee daily lab activities including scheduling of lab staff.

*Provide feedback on performance of analysts.

Country: USA, State: Massachusetts, City: Devens, Company: Bristol-Myers Squibb.