Supervisor, Production Support - RMOMAL

United Therapeutics Corporation

4d • Onsite

About The Position

The Regenerative AlloLung 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.

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.
• Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce departmental and Company policy and procedures as they relate to manufacturing requirements.
• Ability to handle confidential Company data, projects, information, etc.
• Experience with laboratory instrumentation and data software
• Ability to work flexible hours, including weekends or shift work, in a 24/7 operation.

Responsibilities

• 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

Benefits

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
• For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees