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Scientist I – Microbiology

Scientist I – Microbiology

CompanyBristol Myers Squibb
LocationIndianapolis, IN, USA
Salary$96148 – $116500
TypeFull-Time
DegreesBachelor’s, Master’s
Experience LevelSenior, Expert or higher

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