Manufacturing Associate I - Fill Finish - 2nd Shift

California, US residents click here.

The job details are as follows:

Who We Are

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.

Who You Are

As a Manufacturing Associate I, Fill Finish (2nd Shift), you’ll play a hands‑on role in producing sterile drug products that patients and families depend on. You'll support fill‑finish operations by operating equipment, preparing materials, completing cGMP documentation, and maintaining a clean, compliant production environment. This role is ideal for someone who takes pride in precision, follows procedures with care, and enjoys being part of a collaborative manufacturing team where quality and safety come first. The Manufacturing Associate I, Fill Finish (2nd shift) provides process support for the production of drug products under strict adherence to cGMP, OSHA, and United Therapeutics policies and regulations in the Silver Spring, Maryland facility.

• Assist with operating process equipment under strict adherence to cGMP, OSHA, and United Therapeutics policies and regulations ensuring that the production areas and all equipment are clean and in orderly operating condition
• Utilize understanding of equipment to perform basic steps necessary to manufacture
• Monitor basic work processes, ensure components, materials and supplies are stocked prior to the start of the filling operations to assure compliance and completion of targets
• Provide necessary support for all production activities associated with production work
• Receive production raw materials
• Perform basic troubleshooting and assist with technical issues
• Complete general and triennial basic changes to SOPs and other manufacturing documents within limited scope
• Work on basic routine assignments per written procedures and batch records of basic scope with guidance from senior associates
• Complete all required documentation for proper traceability of a production lot
• Complete all cGMP training documentation within a pre-defined timeframe in order to ensure compliance
• Other duties as assigned

Minimum Requirements

• H.S. Diploma or General Education Degree (GED)
• 2+ years of experience in cGMP pharmaceutical manufacturing environment with a H.S. Diploma/GED or Associate's Degree or 0+ years of experience in cGMP pharmaceutical manufacturing environment with a Bachelor's Degree
• Ability to handle confidential company data, projects, and information
• Ability to see, discern, and distinguish colors ("trichromatic")
• Ability to interact with other departments effectively
• Ability to objectively, accurately, and thoroughly convey complex issues in writing
• Proficiency with Microsoft Office or equivalent
• Written and verbal communication skills
• Flexibility to work weekends in rare instances

Preferred Qualifications

• Associates Degree in a scientific discipline or related field or
• Bachelor’s Degree in a scientific discipline or related field
• 1+ years of experience in gowning procedures in a cGMP environment
• 1+ years of experience with sterile aseptic fill operations and equipment
• 1+ years of experience with manual / visual inspection of