Belcan Corporation
Job Title: Microbiologist (Mid)
Location: Berkeley, CA
Zip Code: 94710
Keywords: #Berkeleyjobs; #Microbiologistjobs.
Start Date: Immediate
Position Summary This position is to support related QC Assay testing/validation for the Inspire-01 project.
Position Duties & Responsibilities
Capable of conducting microbiological method validation including bioburden, sterility, LAL (endotoxin), and virology methods supporting biopharmaceutical, clinical and development products. Responsibility includes protocol and report write‑up.
Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
Familiar with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
Investigates questionable test results, writes protocol deviation report (PDR), investigation/test plans when applicable. Collaborates effectively with Quality Assurance validation on the method validation approach.
Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Writes protocols, revises SOPs affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).
Prior experience in a QC microbiology testing laboratory.
Ability to work independently with minimum supervision.
Requirements / Preferences
Minimum Education: Bachelor’s degree in microbiology or related science degree or technical field.
Minimum Experience: 2+ years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.
Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
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Position Summary This position is to support related QC Assay testing/validation for the Inspire-01 project.
Position Duties & Responsibilities
Capable of conducting microbiological method validation including bioburden, sterility, LAL (endotoxin), and virology methods supporting biopharmaceutical, clinical and development products. Responsibility includes protocol and report write‑up.
Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
Familiar with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
Investigates questionable test results, writes protocol deviation report (PDR), investigation/test plans when applicable. Collaborates effectively with Quality Assurance validation on the method validation approach.
Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Writes protocols, revises SOPs affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).
Prior experience in a QC microbiology testing laboratory.
Ability to work independently with minimum supervision.
Requirements / Preferences
Minimum Education: Bachelor’s degree in microbiology or related science degree or technical field.
Minimum Experience: 2+ years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.
Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
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