Manager, QC Chemistry - Combo Products

United Therapeutics Corporation-posted 3 months ago
Full-time • Manager
NC
1,001-5,000 employees
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United Therapeutics seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. The Manager, QC Chemistry will ensure the timely and accurate testing of materials and UTC combination products while maintaining and ensuring all quality and compliance requirements are satisfied. This role will provide oversight and guidance on day-to-day activities of chemists and biochemists in the Combination Products QC laboratory, defining and proposing solutions for technical problems within their scope of work, and serve as an internal technical expert in physical, chemical, and biochemical testing activities utilized by UTC. Responsibilities include preparing, reviewing, and approving related documentation and activities that support process validations, material or process changes, and stability testing for development products. The position requires a hands-on approach to support Quality Control testing and to build out and lead a team.

  • Provide management oversight of QC laboratory operations for all defined QC testing activities including incoming materials, in-process samples, and drug substance and drug product testing.
  • Oversee departmental training including generation, review, and approval of training plans, delivery of hands-on training as needed, monitoring for departmental training compliance.
  • Lead/support QC continuous improvement initiatives related to compliance/quality requirements, introduction of new products/processes, and technical operations.
  • Conduct or provide management oversight of QC-specific investigations and deviations related to testing or other QC processes.
  • Ensure appropriate management of departmental inventories to ensure resources are available and acceptable for use.
  • Prepare, review, and approve SOPs, test methods, and product specifications to ensure alignment with regulatory requirements.
  • Oversee and ensure QC laboratory support for the qualification and validation of laboratory instrumentation.
  • Ensure department safety requirements are met, including proper storage of chemicals and standards.
  • Ensure laboratory metrics are reported in an accurate and timely manner and that those metrics are meeting established performance standards.
  • Direct and manage team to include responsibility for goal setting, performance evaluations, coaching, mentoring and career development.
  • 8+ years of relevant experience in a GMP pharmaceutical QC laboratory with a Bachelor's Degree or 6+ years of relevant experience with a Master's Degree.
  • 2+ years of experience providing oversight or technical leadership in a GMP pharmaceutical QC laboratory setting.
  • Experience scheduling/prioritizing all assigned testing activities related to commercial manufacturing operations.
  • Knowledgeable of FDA cGMP requirements and familiar with USP testing requirements for pharmaceutical and/or biological drug substance and product.
  • Excellent computer application skills required with expertise in Microsoft Suite applications as well as chromatography application programs and LIMS systems.
  • Hands-on laboratory instrumentation experience and expertise in HPLC, GC, UV/VIS, and FTIR.
  • Experience incorporating project testing activities for remediation activities, new project/product support.
  • Experience and expertise with investigative techniques including OOS methodology, root cause analysis, statistical sampling and shelf life projection tools.
  • Technical and leadership experience in GMP, small molecule, pharmaceutical Quality Control laboratory.
  • Experience developing and validating new test methods, executing test method transfer protocols, and qualification of laboratory equipment protocols.
  • Experience coordinating testing and resolving problems with contract testing laboratories to meet commercial product timelines.
  • Experience with resource allocation for a commercial QC laboratory.
  • 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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