Manager, QC Chemistry - 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 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.

• 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 m