Supervisor, Bulk Manufacturing (Dry Powder Inhalation)

California, US residents click here.

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
United Therapeutics supplies Dry Powder Inhalation (DPI) medicines from the RTP, NC facility. This Supervisor is responsible for overseeing the setup, operation, and cleaning of all Bulk manufacturing operations equipment, ensuring that all machines within the supervised area(s), run efficiently and meet operations targets. The Bulk Supervisor will also lead a team of technicians, assigning tasks, monitoring performance, coaching and mentoring, and ensuring the smooth flow of operations across different workstations.
 

• Provide leadership and guidance to technicians assigned to a given operations area, including but not limited to: performing and documenting all start-up checks, in-process checks, equipment adjustments, and batch reconciliations
• Effectively direct and manage direct reports to include responsibilities for training, goal setting & achievement, coaching, mentoring; provide input to performance evaluations, and support career development, retention, and recruitment process. Promote open communication, address concerns promptly, and foster a positive and collaborative work environment while ensuring an uninterrupted operations flow.
• Responsible for scheduling of operations personnel based on daily deliverables and personnel constraints
• Effectively communicate operations needs and/or issues with leadership
• Coordinate with warehouse staff for components needed for each operation; with QA staff for batch record issuance, room clearances and batch record checks as required; with manufacturing staff to issue labels and manage additional staffing needs; with maintenance staff for equipment troubleshooting and preventative maintenance
• Ensure all operations completed in full compliance with company SOPs as well as GMPs. Ensure batch documentation as well as all cleaning records and labels are complete and accurate. Participate in resolving any non-conformance events; responsible for strict adherence to all OSHA and Company Safety Policies.
• Author SOPs, batch documents and investigation reports
• Perform all other duties as assigned

For this role you will need

Minimum Requirements

• H.S. Diploma or General Education Degree (GED)
• 9+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with a H.S. Diploma/GED or
• 7+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with an Associates Degree or
• 5+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with a Bachelor's Degree
• Must have (or be willing and able to obtain) a valid Passport
• Ability to navigate sophisticated equipment control systems on semi- and fully automated pharmaceutical equipment
• Familiarity with the use and operation of in-process test equipment such as scales, balances, torque tester, and count checker
• Experience with GMP documentation requirements
• Must possess excellent written and oral communication skills
• Ability to interact with other departm