Microbiological Scientist

Location: Thousand Oaks CA

Onsite Flexibility: Hybrid 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; all candidates must be near the location for onsite work.

• Position Type: Contract
• Contract Duration: 6 months
• Pay Rate: $35.00$40.00 / Hour (USD)
• Shift / Schedule: Day shift 8:00 AM 5:00 PM
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

The Scientist will support microbiology-related methods such as endotoxin bioburden sterility and other compendial methods associated with microbial control. Hands-on laboratory work includes 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 be required 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 is 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.

• Work on validations/studies to support QC labs as needed (e.g. rapid micro methods LER troubleshooting)
• Help develop/execute sterile filter validations internally
• Attend meetings with QC
• Assist in reviewing regulation and pharmacopeia changes and determine overall impact as well as protocols/summary reports executed by contract testing labs
• Provide micro method technical support as needed

• Experience in QC Microbiology Lab
• Knowledgeable on regulations (FDA CFRs EMA Annex 1 Pharmacopeias)
• Experience in troubleshooting methods (endotoxin/LER) and sterile filter validation

• Prior experience in Microbiological Quality at the technical level including experience with sterile filtration validations
• Advanced understanding and hands-on experience in various analytical platforms 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

• Doctorate Degree OR Masters Degree and 4 years of Scientific Experience OR Bachelors Degree and 6 years of Scientific Experience

• Industry experience in biopharmaceutical manufacturing is ideal

• Experience in pharmaceutical/biotechnology microbiology and manufacturing

• Medical Vision and Dental Insurance Plans
• 401k Retirement Fund

• Interview process: Initial phone screen; if selected on-site interview with the team.

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking financial services technology life sciences biotech utilities and retail sectors throughout the U.S. and Canada.

Job Number: 26-10620

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