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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.