Scientist – QC Microbiology

Infotree Global Solutions; Thousand Oaks (CA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Infotree Global Solutions is seeking a Scientist to support microbiology methods including endotoxin, bioburden, sterility and related compendial assays in a cGMP environment. The role combines hands-on laboratory work with troubleshooting and evaluation of rapid microbiology technologies, feasibility, and validation studies.

You will collaborate with Process Development, Manufacturing, and Quality to drive investigations, ensure regulatory compliance with FDA CFRs and EU guidelines, and

Qualifications

• Doctorate Degree OR Master’s Degree and 4 years of Scientific Experience OR Bachelor’s degree and 6 years of Scientific experience
• Experience in Microbiological Quality at technical level, including sterile filtration validations
• Advanced understanding and hands-on experience in 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 documentation, presentation and discussion of scientific results in a fast-paced, multi-disciplinary environment
• Advanced ability to analyze and interrogate analytical data sets to drive investigations
• Advanced root cause analysis capabilities including leading advanced and complex events
• Expert in an investigational laboratory setting within a pharmaceutical or biotechnology company
• Advanced experience working with scientific and manufacturing disciplines across process development, clinical, and commercial operations
• Familiarity with cGMP regulations, FDA and EU regulations and guidelines

Responsibilities

• Support microbiology methods such as endotoxin, bioburden, sterility, and other compendial methods for microbial control.
• Hands-on lab work including method troubleshooting and evaluation of rapid microbiology technologies.
• Develop and execute feasibility and/or validation studies.
• Work in the lab to support feasibility/validation studies; time spent varies by project.
• Collaborate with Process Development, Manufacturing, and Quality.

Skills

Microbiology

Quality Assurance

cGMP

Regulatory Knowledge

Data Analysis

Troubleshooting

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Experience in QC Microbiology Lab; Knowledgeable on regulations (FDA CFRs, EMA Annex 1, Pharmacopeias);

Experience in troubleshooting methods (endotoxin/LER) and sterile filter validation.

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

All candidates must be near the location for onsite work.

Working Schedule: Dayshift 8 - 5 PM

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

Job Description:

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.

Basic Qualifications:

Doctorate Degree OR Master’s Degree and 4 years of Scientific Experience OR Bachelor’s degree and 6 years of Scientific experience

Preferred Qualifications:

• 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