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Scientist I – Microbiology
Company | Bristol Myers Squibb |
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Location | Indianapolis, IN, USA |
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Salary | $96148 – $116500 |
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Type | Full-Time |
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Degrees | Bachelor’s, Master’s |
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Experience Level | Senior, Expert or higher |
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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