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. 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. All your information will be kept confidential according to EEO guidelines. Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at . Its a simple route driver job and company will be providing the car.