Microbiology Specialist

Overview

Hybrid set up:
All candidates must be willing to work 5 days onsite when needed but can also be remote depending on the schedule or agreement with the hiring manager.

Job Description:

Ideal candidate:
Candidates that have industry experience in biopharmaceutical manufacturing.

Scientist will support microbiology related methods such as, endotoxin, bioburden, sterility and other compendial methods associated with microbial control. Hands on laboratory work include method troubleshooting, and involvement in evaluating new technologies related to rapid microbiology methods, including developing and executing feasibility and/or validation studies.

The candidate will require to work in the laboratory to support feasibility and/or validation studies (time spent in lab varies depending on projects). Experience in pharmaceutical/biotechnology microbiology and manufacturing are preferred.

The candidate would be a part of a team that supports various microbiology methods in various stages of the product life cycle. This team supports programs/methods at locations throughout the company. The Scientist collaborates with representatives from key functions within Process Development, Manufacturing, and Quality.

• This position is being opened to support sterile filtration validation testing. This is a new job responsibility for my team. Team member will assist with developing methods, creating documents to support this work. This team member will also be assisting in the execution/testing of sterile filter validations
• The candidate will require to work in the laboratory to support feasibility and/or validation studies (time spent in lab varies depending on projects). Experience in pharmaceutical/biotechnology microbiology and manufacturing are preferred.
• The candidate would be a part of a team that supports various microbiology methods in various stages of the product life cycle. This team supports programs/methods at locations throughout the company. The Scientist collaborates with representatives from key functions within Process Development, Manufacturing, and Quality.

• Experience with Microbiology methods such as Endotoxin, Bioburden and Sterility
• Experience with Sterile Filter Validation (working with Brevundimonas diminuta)
• Experience working at a biopharmaceutical manufacturing site

• Masters degree and 2 years of experience OR
• Bachelors degree and 4 years of experience

• Prior experience in Microbiological Quality at the technical level, including experience with sterile filtration validations
• Advanced understanding and hands-on experience in various analytical platform such as compendial microbial methods, rapid methods for microbial detection/identification and advanced technologies for detection of bacteria
• Excellent written and oral communication skills for the timely documentation, presentation and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment.
• Advanced ability to critically analyze and interrogate various analytical data sets (e.g. complex dilution schemes) to drive and influence the investigational process
• Advanced root cause analysis capabilities including leading advanced and complex events
• Advanced ability to propose and lead new scientific imperatives/initiatives
• Expert in an investigational laboratory setting within a pharmaceutical or biotechnology company
• Advanced experience in working closely with scientific and manufacturing disciplines across process development, clinical, and commercial operations
• Familiarity with cGMP regulations, FDA and EU regulations and guidelines

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