Manager, QC Chemistry - Combo Products

Manager, Qc Chemistry

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

You thrive in an environment where you can be both hands-on supporting Quality Control testing as well as build out and lead a team around you. You're well versed in a variety of QC instrumentation and want to challenge yourself as a member of a brand new team. 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:

• 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, including oversight of assigned product development (R&D) testing and contract laboratory testing
• Oversee departmental training including generation, review, and approval of training plans, delivery of hands-on training as needed, monitoring for departmental training compliance, development of new training requirements as needed, and retraining needs and frequencies
• Lead/support QC continuous improvement initiatives related to compliance/quality requirements, introduction of new products/processes, and technical operations, including evaluating emerging technologies, new instrumentation, and alternate methodologies and recommending implementation, as appropriate
• Conduct or provide management oversight of QC-specific investigations and deviations related to testing or other QC processes
• Ensure appropriate management of departmental inventories (i.e., equipment, standards, chemicals, etc.) to ensure resources are available and acceptable for use, including coordination with other departments to support equipment such as calibration or validation activities, inventorying materials, and coordinating disposals, as needed
• Prepare, review, and approve SOPs, test methods, and product specifications to ensure alignment with regulatory requirements, internal quality standards, and industry best practices
• Oversee and ensure QC laboratory support for the qualification and validation of laboratory instrumentation, test method transfers, and other analytical testing protocols. Responsibilities include preparing, reviewing, and approving related documentation and activities that support process validations, material or process changes, and stability testing for development products
• Ensure department safety requirements are met, including proper storage of chemicals and standards, equipment and laboratory are in good repair, employee concerns are addressed, and awareness of hazards is communicated and followed through. Responsibilities include working with EHSS to assess challenges, introductions of new materials or reagents, disposal of materials, reagents, and equipment, etc.
• Ensure laboratory metrics are reported in an accurate and timely manner and that those metrics are meeting established performance standards. Actively address any metrics that are indicating performance at an unacceptable level
• Direct and manage team to include responsibility for goal setting, performance evaluations, coaching, mentoring and career development

For this role you will need:

Minimum Requirements:

• 8+ years of relevant experience in a GMP pharmaceutical QC laboratory with a Bachelor's Degree or 6+ years of relevant experience in a GMP pharmaceutical QC laboratory 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 including incoming sampling and testing, in-process testing, finished drug substance or drug product testing, and registration and annual stability programs
• 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 must include basic instrumentation troubleshooting
• Experience incorporating project testing activities for remediation activities, new project/product support (development, validation, etc.), implementation/maintenance of laboratory systems such as LIMS, and training performance into existing schedules to ensure customer departments needs are addressed
• Experience and expertise with investigative techniques including OOS methodology, root cause analysis, statistical sampling and shelf life projection tools, etc.
• 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 (IQ, OQ, PQ)

Preferred Qualifications:

• Experience coordinating testing and resolving problems with contract testing laboratories to meet commercial product timelines
• Experience with resource allocation for a commercial QC laboratory

United Therapeutics requires this candidate to be 100% on-site at our Durham, NC locations.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical/dental/vision/prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.