Scientist - QC Microbiology in Newbury Park, California

Job Title

Scientist

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

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.

Dayshift 8 - 5 PM

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.

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