Supervisor, Production Support - RMOMAL

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Supervisor, Production Support (RMOMAL)

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.

The Regenerative Allo Lung Manufacturing, Production Support Supervisor is responsible for leading a team of Biomanufacturing Associates who perform support activities such as washing, autoclaving, single-use assemblies, media/buffer compounding, restocking, coordinating equipment Cal and PM within a cGMP-compliant environment. This role oversees the efficient execution of daily operations while ensuring adherence to regulatory standards, safety protocols, and internal quality systems.

• Supervise and perform day to day activities with Biomanufacturing Associates
• Ensure resource availability as required by Scaffold Center, Recellularization group, Cell Production group to meet manufacturing production targets, including building enough inventory of single use assemblies, compounding media and buffers, washing and autoclave in a timely manner, restock items, coordinating PM and Cal activities etc.
• Collaborate with the procurement team and inventory team to monitor raw material usage rates and maintain accurate inventory levels
• Promote a culture of safety and ensure adherence to all OSHA regulations and company safety policies
• Ensure all operations comply with cGMP regulations, internal SOPs, and applicable OSHA and Unither safety policies
• Review manufacturing documentation, including batch records, deviations, and corrective actions
• Initiate and support investigations when process deviations or non-conformances occur
• Create, review, and revise SOPs and manufacturing procedures to reflect current practices and regulatory expectations
• Participate in department and corporate teams and initiatives
• Conduct performance evaluations, set objectives, and support career development through coaching, mentoring, and development plans
• Foster a collaborative and accountable team environment
• Deliver and document on-the-job training for new and current staff on production processes, equipment, and safety procedures
• Support development of technical competencies across the team
• Assist with the implementation, qualification, and validation of new equipment and process upgrades
• Support routine equipment troubleshooting and optimization efforts
• Perform additional responsibilities as assigned by leadership

Minimum Requirements

• Bachelor’s Degree in bioengineering, biology, cell and molecular biology, biomedical science, or other related field
• 5+ years of post-baccalaureate experience in pharmaceutical or biotechnology industry (cGMP environment)
• 1+ Years Supervisory experience
• Working knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards. Ability to apply GMP to company specific processes and products.
• Ability to assist with on-going production issues such as investigations, optimization efforts and scheduling/logistical issues
• Ability to effectively manage a diverse group of skilled manufacturing associates
• Demonstrated leadership skills
• Knowledge of SAP or similar inventory management system
• Ability to navigate sophisticated HMI control systems on automated pharmaceutical manufacturing equipment
• Familiar with the use and operation of equipment such as parts washer, autoclave, biological safety cabinets, fume hoods, balances, pipettes, freezers, fridges etc.
• Excellent professional documentation and verbal communication skills. Ability to objectively, accurately, and thoroughly convey complex issues in writing. Ability to produce a large volume of written materials independently.
• Ability to interact with other departments effectively.…