Microbiologist

Job Description Provide microbiology support for pilot plant facilities and project teams to ensure microbiology data meet compendial and quality standards. Key Responsibilities Co-ordinate or perform appropriate microbiology testing to support release of finished products or testing of stability samples for clinical product manufacture. Review microbiological test results from in house or contract microbiological testing labs for completeness, accuracy, and quality, in addition to assessing trends to draw conclusions. Defining or reviewing the microbiological control strategies for drug products (both API and Formulations). Provide CMC regulatory submission support with respect to microbiology for milestone studies. Maintain partnership with clinical manufacturing and product development teams to provide timely and high quality data and service. Develop and propose specifications, sampling instructions, test methods and other Quality Control procedures. Maintain training records and familiarity with current SOPs and controlled documents. Proactively seek assistance from other scientists to solve problems. Works to GMP standards as appropriate. Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements. Competencies Bachelors Degree in Microbiology/ Biology with pharmaceutical experience in sterile and non-sterile product microbiological procedures, method development, validation and testing of API/drug products. General compendial knowledge of the USP Microbiology. Experience with GMP requirements for Microbiology laboratory and clinical manufacturing plants. Excellent verbal and written communication skills. Ability to prioritize and organize tasks. Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr