Microbiological Scientist

Scientist - Microbiological

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.

Contract Details

• 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.

Job Summary

TheScientist 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 withinProcess Development, Manufacturing, and Quality.

Key Responsibilities

• 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

Required Skills

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

Preferred Skills

• 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

Education Requirements

• Doctorate Degree OR Master's Degree and 4 years of Scientific Experience OR Bachelor's Degree and 6 years of Scientific Experience

Required Experience

• Industry experience in biopharmaceutical manufacturing is ideal

Nice-to-Have Experience

• Experience in pharmaceutical/biotechnology microbiology and manufacturing

Benefits

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

Important Notes

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

About GTT

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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