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Microbiology Manager

3 months ago

Bloomington, Indiana, United States PeopleShare Full time
Exciting Career opportunity for an experienced Microbiology Manager within the Pharmaceutical industry located in the Charlotte Metro area. Benefits include:
  • Incentive and Recognition Program
  • Healthcare Benefits
  • Disability and Life Insurance
  • Employee Assistance Program
  • Paid Vacation and Holidays
  • Retirement Benefits/ 401K
  • Sick Pay and Medical Leave
  • Health and Fitness Program

The Microbiology Manager serves as the main contact for the microbiology lab, working with other departments, ensuring accurate and timely data management and reporting, and supporting manufacturing timelines and regulatory standards.Responsibilities:
  • Assist in preparing OpEx and CapEx budgets, ensuring resource allocation within approved limits while maintaining high-quality processes.
  • Implement strategies to minimize waste and enhance efficiency in analysis.
  • Provide daily logistical support to coordinate activities and projects.
  • Oversee testing of in-process, final product, and stability samples.
  • Review and approve data and procedures for batch release.
  • Address technical issues, coordinate investigations, and ensure compliance and timeliness.
  • Write, evaluate, and approve deviation and investigation reports.
  • Supervise, mentor, and develop staff to ensure compliance with cGMP and regulatory requirements.
  • Conduct annual performance reviews and set objectives for direct reports.
  • Prepare the lab for audits and participate as a subject matter expert.
  • Update standard operating procedures to maintain compliance.
  • Manage instrument calibration and maintenance.
  • Maintain inventory of lab reagents, media, and supplies.
  • Procure and qualify new lab equipment.
  • Review change controls, incidents, protocols, and deviations related to microbiology.
  • Complete gown qualification program.
  • Manage performance of microbiology lab personnel.
  • Coordinate with Production, R&D, QA, and QC on microbiology-related activities.
  • Address OOT, OOAC, OOAL, and OOS observations.
  • Train staff on cGMP practices in microbiology.
  • Stay updated with regulatory requirements and update SOPs accordingly.
  • Suggest improvements for lab procedures and practices.

Qualifications:
  • BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent; a Master's degree in Microbiology is preferred.
  • 5-7 years of experience in pharmaceutical microbiology, preferably with injectables.
  • Quick learner with strong understanding of complex topics.
  • Prefer industry experience over academic experience.
  • Proficient in microbiology lab skills, including aseptic techniques.
  • Knowledge of cGMPs, cGLPs, FDA regulations, and international guidelines.
  • Excellent written and verbal communication skills.
  • Ability to prioritize and manage multiple projects.
  • Strong organizational, analytical, troubleshooting, and problem-solving skills.
  • Independent worker with good judgment and a strong work ethic.
  • Experience with regulatory audits.

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