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Lead Pharmaceutical Manufacturing Technician - Upstream

Build and optimize GMP-compliant manufacturing processes for engineered organ production
North Carolina, United States
Senior
14 hours agoBe an early applicant
Iviva Medical

Iviva Medical

Develops bioengineered organ and tissue regeneration therapies using advanced cell biology, biomaterials, and 3D bioprinting technologies.

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Manufacturing Operations Leader

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.

You are a builder at heart—someone who thrives in a startup-like setting where creating structure and driving innovation go hand in hand. You're excited by the challenge of shaping a new manufacturing operation from the ground up, writing SOPs, and establishing best practices that will set the standard for excellence. With deep technical expertise and a passion for continuous improvement, you lead by example—training others, troubleshooting complex issues, and ensuring every process aligns with cGMP and safety requirements. If you're energized by the opportunity to make a lasting impact and leave your mark on a cutting-edge facility, this is the role for you.

  • Weigh raw materials per Production Batch Record specifications to ensure products are properly formulated
  • Operate, clean, and maintain pharmaceutical manufacturing equipment, including mixers and homogenizers, transfer pumps, filtration systems, spray dryers, and blenders, with limited supervision ensuring the efficient production of quality product
  • Lead and coordinate daily activities of assigned team of manufacturing operators such that all batches are completed in full compliance with company SOPs as well as GMPs
  • Monitor and audit the production of assigned pharmaceutical batches, ensuring they are manufactured according to schedule, cGMP and company SOPs, while maintaining a focus on efficiency and accuracy
  • Provide guidance to other technicians during the execution of batches in the production process
  • Review batch manufacturing documentation as well as all cleaning records and labels to ensure accuracy and adherence to cGMP and SOPs
  • Complete all basic process, cGMP, and safety training within the pre-defined time frame to ensure compliance
  • Assist management in the governance of training curriculum completion by other team members
  • Provide relevant process, cGMP and safety training to other technicians; perform On The Job Training (OJT) for new and developing staff.
  • Achieve Subject Matter Expert (SME) status on multiple processes within the manufacturing area of the DPI process
  • Troubleshoot and resolve production problems of moderate to advanced complexity, and escalate issues that require management involvement or decision-making; proactively coordinate with maintenance on complex equipment issues
  • Participate in all aspects of moderate to complex process deviations, investigations, change controls, and corrective actions
  • Author and review SOPs and batch documentation, and suggest improvements to SOPs and other documents as appropriate
  • Identify, recommend, develop, and implement process improvements
  • Adhere to all OSHA and Company Safety Policies

For this role you will need

Minimum Requirements

  • 6+ years of relevant hands-on experience in a regulated production environment with a H.S. Diploma/GED or Associate Degree OR 4+ years of relevant hands-on experience in a regulated production environment with a Bachelor's Degree
  • Strong cGMP documentation practices
  • Experience with production equipment within a regulated industry
  • Ability to navigate sophisticated HMI control systems on automated equipment
  • Demonstrated ability to work effectively in a team
  • Demonstrated leadership of peers within a regulated production environment
  • Ability to work shifts to cover a 24/7 operation
  • Ability to work shifts to cover a 3 shift 5 day or 24/7 operation
  • Strong verbal and written skills with the ability to understand and clearly communicate both orally and in writing in English
  • Basic computer skills

Preferred Qualifications

  • Associate Degree in a scientific discipline or a related field or
  • Bachelor's Degree in a scientific discipline or a related field
  • Advanced knowledge with production equipment, such as spray dryers, product transfer equipment, isolator technology, and filtration systems
  • Experience with process deviation investigations, CAPA, etc.
  • Familiar with SAP or similar inventory management system

Physical Requirements

This position will require frequent standing and walking, as well as pushing and pulling up to 1100 pounds. There may be occasional lifting and carrying up to 50 pounds of weight.

United Therapeutics requires this candidate to live near our Durham, NC office. This position will need to be on-site 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.

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Lead Pharmaceutical Manufacturing Technician - Upstream
North Carolina, United States
Hardware
About Iviva Medical
Develops bioengineered organ and tissue regeneration therapies using advanced cell biology, biomaterials, and 3D bioprinting technologies.