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Manufacturing Associate III - Cell Culture

Company: United Therapeutics Corporation
Location: Silver Spring
Posted on: June 6, 2021

Job Description:

The Job Details are as follows:

What we do

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.

We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

How you'll contribute

The Manufacturing Associate III - Cell Culture is responsible for supporting the manufacture of monoclonal antibody products under cGMP regulations. In this role, you will troubleshoot process and equipment issues and maintain training documentation including SOPs. Using your expertise, you will also train other operators in cGMP compliance and processing.

Key job responsibilities

  • Operate bioprocess equipment under strict adherence to cGMP, OSHA, Unither policies, and regulations under general supervision.

  • Weigh raw materials per Production Batch Records specifications.

  • Conduct vial thaw and cells' expansion through various stages.

  • Work aseptically in a Biological Safety Cabinet.

  • Prepare buffers from stock raw materials per Production Batch Records specifications.

  • Monitor and audit work processes to ensure compliance and completion of target.

  • Review and/or execute related documentation.

  • Maintain personal cGMP training to ensure compliance.

  • Collaborate with process development on technical transfer issues.

  • Work on problems of moderate scope with analysis of situations or data.

  • Identify, develop, and recommend process improvements to management.

  • Contribute ideas to resolution of routine production problems.

  • Support closure of process deviations, investigations and corrective actions.

  • Conduct basic process, cGMP and safety training.

  • Within a limited scope, write and review area SOPs and Production Batch Records.

  • Perform daily cleaning and sanitization of the manufacturing equipment.

  • Assist senior staff in implementing different projects.

  • Provide guidance to junior staff when running batches.

  • Perform other duties as assigned.

For this role you will need

Minimum Qualifications

  • H.S. Diploma or General Education Degree (GED)

  • 4+ years of related biotech manufacturing experience

  • 4+ years of dedicated Downstream/Upstream manufacturing experience

  • 1+ years demonstrated upstream/cell culture experience in monoclonal antibody products

  • 1+ years demonstrated experience operating equipment including depth filtration, cells inoculation, pumps, mixers, and product hold tanks

  • 1+ years of experience with troubleshooting of bioreactors, product hold tanks and CIP Skids

Preferred Qualifications

  • Bachelor's degree in Arts/Sciences (BA/BS) in scientific discipline or a related field

  • 1+ years experience in Cell expansion

  • 1+ years experience conducting inventory management

  • 1+ years experience with solution preparation

  • 1+ years experience with bioreactors and CIP Skids

  • 1+ years experience in supporting written deviations and conducting area investigations

Life as a Unitherian

At United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

Keywords: United Therapeutics Corporation, Silver Spring , Manufacturing Associate III - Cell Culture, Other , Silver Spring, Maryland

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