Manager, QC Microbiology - Combo Products

California, US residents click here.

The job details are as follows:

Who We Are

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.

Who You Are

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

Minimum Requirements

• 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 phar