Manager, QC Microbiology - Combo Products

Manager, Qc Microbiology

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 want to be challenged by joining a 'greenfield' project. You're excited about the opportunity to be on the bench each and every day as you work to build out a top-notch QC Microbiology team. 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, including oversight of third party contract laboratories as applicable
• Plan and execute method validation protocols for API, intermediates, drug substance, and drug product release and testing, as well as qualification and validation protocols for laboratory instrumentation
• 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 (i.e. equipment, standards, media, organisms, chemicals, etc.) to ensure available resources are current and acceptable for use, including coordination with other departments to support equipment such as calibration or validation activities, inventorying of materials, and disposal as needed
• Lead and support continuous improvement initiatives related to compliance/quality requirements; introduction of new products/processes, and technical operations requirements
• Ensure department safety requirements are met, including proper storage of chemicals/standards, equipment/facility is in good repair (with regard to safety requirements), employee concerns are addressed, and awareness of hazards is communicated and followed-through
• 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. Oversee and support recruitment and hiring activities as applicable

For this role you will need

• 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, but not limited to: Microbial Limits Testing (MLT), Bacterial Endotoxyn 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

Preferred Qualifications

• 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

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.