Irvine Pharmaceutical Services, Inc., is growing and we have a need for an experienced Microbiologist that has excellent supervisory skills for a very busy, fast paced department. If you meet the qualifications below, we would like to hear from you!

Please, only apply if you meet the qualifications and experience listed below. Thank you.

The Microbiology Supervisor/Sr. Supervisor/Assosiate Manager will perform in a cGMP environment following FDA and ICH guidelines. Responsibilities include scheduling, assignment and testing of microbiology samples. Must have experience in developing and validating methods, fluency in compendial testing such as Bioburden, Microbial Limits (preparatory & screening), Sterility, Endotoxin (Gel-Clot & Kinetic Chromogenic methods), validation - Inhibition/Enhancement and Sterility Test Method Validation (Bacteriostasis/Fungistasis), Bacterial Identification with Biolog using Biolog Identification System, Preservative Efficacy Testing, Environmental Monitoring, familiarity with validation of and writing protocols for instruments and equipment, excellent knowledge in GMP and ISO requirements, experience and understanding of regulations and test procedures for medical devices are required. Additionally, knowledge and experience in regulations for drug development pertaining to microbiologyThis position requires the ability to supervise employees and have good problem solving abilities.

This position requires:

• B.S. Degree in Microbiology with at 8+ years, or equivalent, of experience in pharmaceutical industry.
• Demonstrated ability to manage multiple projects and meet critical deadlines. Successful candidates must be proactive and creative, well organized, and have excellent communication skills.
• Responsible for assigning the training of new analysts, reviewing their training records. Responsible for reviewing all analytical data generated, sign and date notebook and initial job worksheet, before analyst inputs results into database.
• Responsible for ordering chemicals, standards, lab supplies, etc., in order to get the work done on time.
• Ensure that all instruments, used in their areas, are in good working conditions and that calibrations and maintenance records are up to date. Support and train all lab technicians and associate chemists.
• Provide technical support in the maintenance of lab systems and instrumentation.
• Excellent communication skills (verbal and written)