Senior Manager, Quality Control

The job details are as follows:

What We Do

We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are 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.

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, and other orphan diseases.

How You’ll Contribute

The Senior Manager, Quality Control will ensure the timely and accurate testing of materials and UTC products while maintaining and ensuring all quality and compliance requirements are satisfied. This person will provide oversight and guidance on day-to-day activities of chemists and biochemists in the 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. This can include oversight of 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 frequency.
• Lead/support QC continuous improvement initiatives related to compliance/quality requirements, introduction of new products/processes, and technical operations. This includes evaluating emerging technologies, new instrumentation, and alternate methodologies and recommending implementation, as appropriate.
• Conduct or provide management oversight for 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 available resources are available and acceptable for use. This can include coordination with other departments to support equipment such as calibration or validation activities, inventorying materials, and coordinating disposals, as needed.
• Prepare and/or review and approve SOPs, Test Methods, and Specifications.
• Prepare, review and approve, and ensure QC laboratory support for laboratory instrumentation qualification and validation protocols, test method transfer protocols, and other testing protocols. This can include testing to support process validations, process or material changes, development product stability, etc.
• 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. This can include working with EHS to assess challenges, introductions of new materials or reagents, etc.
• Ensure laboratory metrics are reported in an accurate and timely manner and that those metrics are meeting established performance standards. Actively addresses any metrics that are indicating performance at an unacceptable level.
• Direct the activities of the team including responsibility for goal setting, performance evaluations, coaching, mentoring and career development.
• Perform other duties as assigned.

For this role you will need

Minimum Requirements

• Bachelor’s Degree in Chemistry or related field
• 10+ years of experience in a GMP pharmaceutical QC laboratory and
• 5+ years of experience in a manager role or higher in a GMP pharmaceutical QC laboratory
• Experience scheduling/prioritization of 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 USP testing requirements for pharmaceutical 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 instrumentation troubleshooting
• Experience and expertise with investigative techniques including OOS methodology and FDA expectations, root cause analysis, statistical sampling and shelf life projection tools, etc.
• 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
• Technical and management 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

• Master’s Degree in Chemistry or related field
• Experience coordinating testing and resolving problems with contract testing laboratories to meet commercial product timelines
• Experience with budgeting and resource allocation for a commercial QC laboratory
• Hands-on laboratory instrumentation experience and expertise in Capillary Electrophoresis and ELISA

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.

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

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