Manager, Cell Production - Rmomal

Manager, Cell Production

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 Manager, Cell Production (RMOMAL) will work in a collaborative and dynamic environment during the start-up of a new GMP manufacturing facility focused on tissue engineering. The manager will play a key role in establishing operations and bringing the facility online in partnership with the leadership team. This role is responsible for leading a team of Biomanufacturing Associates engaged in the production of cells used in the production of Regenerative Allolung in a cGMP-compliant environment. This role ensures efficient execution of day-to-day operations while maintaining compliance with regulatory standards, safety protocols, and internal quality systems.

Responsibilities:

• Prepare and manage the cell expansion production schedule for the generation of primary lung cells to meet department goals and production needs
• Routinely oversee and perform large-scale primary lung cell culture in 2D or 3D culture systems to meet department goals and production needs
• Ensure resource availability as required in order to meet manufacturing production targets
• Responsible for long-term capacity and staffing planning
• Collaborate with Scaffold Center, Recellularization team and production support team to meet department goals and production needs
• 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 and approve manufacturing documentation, including batch records, deviations, and corrective actions
• Lead investigations when process deviations or non-conformances occur
• Create, review, and revise SOPs and manufacturing procedures to reflect current practices and regulatory expectations
• Lead department and corporate teams and initiatives
• Conduct performance evaluations, set objectives, and support career development through coaching, mentoring, and development plans
• Provide direct supervision to Biomanufacturing Associates
• Foster a collaborative and accountable team environment
• Define and monitor area training requirements. 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
• 8+ years of post-baccalaureate experience in pharmaceutical or biotechnology industry (cGMP environment)
• 2+ years of direct supervisory experience
• 2+ years of experience with mammalian cell culture, aseptic technique
• Advanced working knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards. Ability to apply GMP to company specific processes and products.
• Ability to lead resolution of on-going production issues such as investigations, optimization efforts and scheduling/logistical issues
• Ability to effectively manage a diverse workforce
• Demonstrated leadership skills
• Track record of developing and retaining employees
• 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 biological safety cabinets, fume hoods, balances, pipettes, freezers, fridges, cell counter, endotoxin readers 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 are relate to manufacturing requirements.
• Ability to maintain confidentiality with Company data, projects, information, etc.
• Ability to work flexible hours, including weekends or shift work, in a 24/7 operation

Preferred Qualifications:

• 1+ years of experience in molecular assays, cellular assays, and fluorescence microscopy

Locations:

This position is located at our Durham, NC office and the successful candidate will be required to be onsite 100% of the time.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

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.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.