Scientist I – Microbiology

Scientist I – Microbiology

Requirements

• BS/MS in Microbiology or relevant scientific field
• 5-10 years’ experience within a pharmaceutical microbiology testing environment and/or environmental monitoring experience in a cGMP/FDA regulated facility required
• Strong experience with cGMP regulations, ICH guidelines, quality systems, and safety guidelines
• Experience with sterile manufacturing required
• Radiopharmaceutical experience preferred but not required

Responsibilities

• Mentor and support the training of microbiology and environmental monitoring (EM) associates
• Prepare, review, and update of Standard Operating Procedures and testing protocols required for GMP microbiology operations in accordance with applicable guidelines (e.g. USP, EP, and ICH)
• Support and perform testing for microbial test method development, qualification and validation for bioburden, sterility, and endotoxin testing
• Support review and approval of sample data, results, and other documents that are generated in the microbiology and environmental monitoring lab
• Prepare and review trending reports for microbiology and environmental monitoring data
• Conduct investigations for quality events and environmental excursions, assist in addressing deviations related to microbiology procedures, and assist in implementing CAPAs as needed
• Participate in troubleshooting activities for utility systems and cleanrooms based on trend analysis of environmental monitoring data
• Participate in the daily operations of microbiology department and its various components, maintaining compliance with company, local, state and federal/ISO policies and regulations
• Participate in internal audits and audits conducted by external agencies and Regulatory Authorities to confirm compliance and identify improvement opportunities
• Support and provide technical, quality, and/or safety information pertaining to microbiological and environmental monitoring tests to lab management on a routine basis
• Assist in the implementation of policies and procedures consistent with those of the organization to ensure efficient and safe operation of the unit
• Work with radiation safety team to ensure laboratory compliance with the radiation safety program at the Indianapolis site
• Develop goals to participate in continuous improvement of the QC department and overall facility
• Perform other duties as required by management.

Preferred Qualifications

• Subject matter expert in various microbiological techniques including bioburden, sterility, and endotoxin testing
• Highly motivated and organized individual with the ability to work both independently and in a team environment
• Ability to multi-task and prioritize work based on multiple workflows
• Strong written and verbal communication skills required
• Excellent professional ethics, integrity, and ability to maintain confidential information
• Work with computer programs, including but not limited to Microsoft Office