Scientist - Microbiology

Celltrion Branchburg, LLC•Branchburg Township, NJ

4d•$71,250 - $116,000•Hybrid

About The Position

The Scientist - Microbiology applies microbiology expertise to conduct routine and assigned non-routine analyses in a compliant manner. The role creates, revises, and reviews technical documents; contributes to special microbiological projects; trains employees on procedures and job functions; and supports coworkers with troubleshooting, laboratory investigations, and problem resolution. The position suggests process improvements to QC management, performs routine QC responsibilities, applies cGMP practices and ALCOA principles, and keeps the supervisor informed of progress. Responsibilities include routine microbiological testing and related QC activities, including testing of water, gas, in-process materials, final products, raw materials, environmental samples, and finished goods. The role also performs material qualifications and inventory control, organism identification, bioburden, endotoxin, sterility, microbial identification, biological indicator, and method suitability testing; prepares and maintains microbial stock cultures; supports validations and other microbiological studies; and ensures laboratory equipment is maintained and calibrated. The position reviews microbiology data and logbooks, performs analytical and deviation investigations, and develops or reviews SOPs, material specifications, protocols, and trend reports. It requires teamwork, communication, attention to detail, independent problem solving, familiarity with Microsoft Office and computerized data systems, and a working knowledge of cGMP regulations. The role may require up to 10% travel, on-call availability, and shift work. Hybrid flexibility may be available based on business needs; relocation assistance is not provided.

Requirements

Excellent teamwork and communication skills.
Strong attention to detail.
Ability to work independently and resolve problems with minimal supervision.
Competence with Microsoft Office programs.
Comfort using computerized data storage systems such as MODA, LIMS, SmartLab, or TrackWise.
Good working knowledge of cGMP regulations.
An associate degree in a related science, such as Biology or Biochemistry, plus at least 2 years of industry experience; or a bachelor's or master's degree in a related science with 0 or more years of industry experience.
Flexibility to work weekends, overtime, and holidays as needed.

Responsibilities

Conduct routine microbiological testing on water, gas, in-process materials, final products, raw materials, environmental and water samples, and finished goods.
Perform material qualifications and QC inventory control.
Identify organisms and perform bioburden, endotoxin, sterility, microbial identification, and biological indicator testing.
Prepare and maintain microbial stock cultures.
Perform method suitability testing, including bacteriostasis and fungistasis testing.
Assist with special projects, including validations and microbiological studies.
Create, revise, or review SOPs, material specifications, protocols, and trend reports for water, environmental monitoring, or invalid assays.
Perform analytical and deviation investigations.
Review microbiology testing data and logbooks.
Train other analysts on procedures as needed.
Maintain laboratory equipment and ensure it is within calibration.
Provide troubleshooting and laboratory investigation support to coworkers and suggest QC process improvements.
Apply cGMP practices and ALCOA principles in work tasks and update the supervisor on progress.