Job Title:
We are seeking a senior microbiologist to join our quality control team.
The ideal candidate will have experience in microbiological testing, method transfers, and sample management.
Main Responsibilities:
* Perform endotoxin testing of water and drug product samples
* Conduct bioburden testing of water and in-process drug product samples
* Carry out sterility testing
* Collect and analyze water samples
* Support laboratory activities such as biological indicator testing, growth promotion, media preparation, identification, and autoclave operation
* Write technical reports
* Maintain and inspect analytical equipment
* Work on weekends for bioburden cover
* Perform analytical testing with efficiency and accuracy
* Collaborate with colleagues across the laboratory
* Plan and execute routine and non-routine methods and procedures
* Review, evaluate, and approve analytical data
* Solve problems and communicate with stakeholders
* Implement changes in controlled documents
* Participate in audits, initiatives, and projects
* Develop protocols and perform assay validation
* Introduce new techniques to the laboratory
* Evaluate lab practices for compliance and operational excellence
* Review and approve lab results
Requirements:
* Bachelor's degree in a science discipline
* Experience in biopharmaceutical QC in a microbiology laboratory
* Familiarity with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products