Quality Control Senior Microbiologist

General Responsibilities:

Performs microbiological and other testing in support of aseptic product manufacturing.

Responsibilities:

• Perform sterility, endotoxin, pH and osmolality testing on raw materials, drug substance, and drug product
• Perform gram stains, sub-culturing of isolates, growth promotion testing, and general cell culture
• Direct Sterile Media Fill Trials and perform support testing, including visual inspection
• Maintain housekeeping and equipment maintenance in the Quality Control laboratories
• Assist the Quality Control department in daily operations, as needed
• Author and revise QC SOPs as necessary to maintain compliance
• Author and execute qualification protocols and reports for microbiological assays
• Timely response to Out of Specification (OOS) results, including notification to area supervision
• Completion of thorough investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented
• Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule
• Perform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing and particulate monitoring, inside the aseptic clean rooms, as necessary
• Oversight of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed
• Training of other employees as necessary

Computer Skills

• To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.

Education:

• Minimum Bachelor of Science degree in a scientific discipline

Experience:

• 4 - 8 years of microbiology experience in the biologics or pharmaceutical industry
• Experience with BacT rapid sterility assay, endotoxin testing, growth promotion, and environmental monitoring required. Experience with cell therapy preferred.
• Knowledge of Current Good Manufacturing Practice and Industry standards
• Experience in aseptic processing and mammalian cell culture production
• Familiarity of basic laboratory equipment such as microscopes, pH meters, incubators
• Excellent verbal, written and organizational skills
• Good interpersonal and communication skills
• Must be open to occasional off shift and weekend work