Manufacturing Associate III - Cell Culture
Company: United Therapeutics Corporation
Location: Silver Spring
Posted on: June 6, 2021
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
Weigh raw materials per Production Batch Records
Conduct vial thaw and cells' expansion through various
Work aseptically in a Biological Safety Cabinet.
Prepare buffers from stock raw materials per Production Batch
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
Work on problems of moderate scope with analysis of situations
Identify, develop, and recommend process improvements to
Contribute ideas to resolution of routine production
Support closure of process deviations, investigations and
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
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
H.S. Diploma or General Education Degree (GED)
4+ years of related biotech manufacturing experience
4+ years of dedicated Downstream/Upstream manufacturing
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
- 1+ years of experience with troubleshooting of bioreactors,
product hold tanks and CIP Skids
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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