Manager, QC Microbiology

United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We will provide any accommodations as required by law.

The job details are as follows:

What We Do

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.

We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

In 2021, we became the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

How you’ll contribute
The Manager of QC Microbiology will manage the day-to-day activities of the QC Microbiology laboratories to ensure the timely and accurate testing of raw materials and products, site process and environmental monitoring activities, and 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 Silver Spring and UT Jacksonville site QC Microbiology Laboratories including raw material testing, product sterility testing, and process/environmental monitoring. This can include oversight of third party contract laboratories as applicable.
• Plan and execute method transfer 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
• Ensure the proper staffing needs of the Microbiology Laboratory are satisfied; oversee and support recruitment and hiring activities as needed
• Oversee and support development and training of microbiologists and other departmental team members.
• Maintain departmental inventories (i.e. equipment, standards, media, organisms, chemicals, etc.) to ensure available resources are current and acceptable for use. This may include coordination with other departments to support equipment such as calibration or validation activities, inventorying of materials, and disposal as needed, etc.
• 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
• Other responsibilities as assigned

For this role you will need

Minimum Requirements

• Bachelor’s Degree in Arts/Sciences (BA/BS) in microbiology or closely-related field
• 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 and
• 3+ years of experience in cGMP pharmaceutical laboratory supervision/management
• Experience in laboratory budgeting
• Experience in microbial method qualifications including, but not limited to: Microbial Limits Testing (MLT), Bacterial Endotoxin Testing (BET), sterility testing, and bioburden testing
• Experienced in training in current good manufacturing practices (cGMP)
• Experienced 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
• Proficiency in using LIMS, LAL and Microbial ID application 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 (MA/MS/MBA) in microbiology or closely-related field
• Management experience with controlled environments in manufacturing
• Experience in new laboratory start-up

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities