United Therapeutics Corporation-posted 3 months ago
Full-time • Mid Level
NC
1,001-5,000 employees

United Therapeutics seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. The Manager, QC Microbiology will manage the day-to-day activities of the QC Microbiology laboratories and team to ensure the timely and accurate testing of raw materials and products, site process and environmental monitoring activities. This role is responsible for the review and approval of testing documentation, while maintaining and ensuring quality and compliance requirements are satisfied. This role is also responsible for defining and proposing solutions for technical problems within their scope of work and serving as an internal technical expert in microbiology and inspection activities to support GMP and R&D work.

  • Provide management oversight of operations for the UT Combination Products QC Microbiology Laboratory, including raw material testing, product sterility testing, and process/environmental monitoring.
  • Plan and execute method validation protocols for API, intermediates, drug substance, and drug product release and testing.
  • Serve as subject matter expert (SME) for all microbiology-related test methods and operational procedures.
  • Prepare and review departmental SOPs, protocols, risk assessments and summary reports.
  • Ensure all deviations, change controls, corrective actions, investigations, etc., are properly documented and completed within the defined time period.
  • Conduct data analysis reviews; prepare and provide metrics reporting data as requested.
  • Maintain departmental inventories to ensure available resources are current and acceptable for use.
  • Lead and support continuous improvement initiatives related to compliance/quality requirements.
  • Ensure department safety requirements are met.
  • Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, and career development.
  • Ensure the microbiology laboratory is properly staffed.
  • 8+ years of experience in cGMP pharmaceutical (or closely related industry) quality control with a Bachelor's Degree or 6+ years of experience in cGMP pharmaceutical (or closely related industry) quality control with a Master's Degree.
  • 2+ years of experience providing oversight or technical leadership in a cGMP pharmaceutical laboratory setting.
  • Experience in laboratory budgeting.
  • Experience in microbial method qualifications including Microbial Limits Testing (MLT), Bacterial Endotoxin Testing (BET), sterility testing, and bioburden testing.
  • Experience in training over current good manufacturing practices (cGMP).
  • Experience in lab equipment qualification (IQ, OQ, PQ) protocol review, writing, and application.
  • Expertise in FDA and compendial (USP, EP, and JP) testing requirements.
  • Experience in stability testing programs.
  • Ability to manage multiple projects or tasks simultaneously, and manage immediate changes in priorities.
  • Ability to troubleshoot problems and present solutions.
  • Effective interpersonal and communication skills in interacting with all levels of individuals from multiple departments across UTC.
  • Proficient computer application skills with expertise in Word and Excel.
  • Master’s Degree in microbiology or closely-related field.
  • Proficiency in using LIMS, LAL and Microbial ID application programs.
  • Experience in new laboratory start-up.
  • Management experience with controlled environments in manufacturing.
  • Medical / dental / vision / prescription coverage.
  • Employee wellness resources.
  • Savings plans (401k and ESPP).
  • Paid time off & paid parental leave benefits.
  • Disability benefits.
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