Cell Culture Process Development Scientist

United Therapeutics Corporation Silver Spring , MD 20901

Posted 2 months ago

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

We are currently looking for a Cell Culture Process Development Scientist to join our Process Development team in Silver Spring Maryland. In this role, you will be responsible for performing mammalian cell culture to support the cell culture process in a new cGMP monoclonal antibody production facility. Additionally, you will perform process development experiments which will be conducted to develop a robust cell culture process. Your work in this role will define the parameters for cGMP manufacturing in the new facility.

  • Responsible for small scale cell culture in development lab to support the transfer and scaling of production processes

  • Development of a qualified down-scale model, optimization of titer, and screening of media components

  • Optimize cell culture process for Phase III/commercial, and require scale-up from 5L to 50 L scale, to enable full-scale process transfer

  • Harvest and clarify the product from the cell culture at the end of the process

  • As new products emerge from research, supporting the development of new cell culture growth media may be required

  • Write development reports to document the development of the cell culture process

  • Support supply/equipment ordering as needed and general lab maintenance

  • Interface regularly with internal stakeholder within the QA/QC and Manufacturing teams

  • Interact with equipment and supply vendors, and service representatives

  • Present development summaries weekly to Process Development and Manufacturing teams

  • Other duties as assigned

For this role you will need

Minimum Requirements

  • Bachelor's degree in Biology, Chemistry, Biochemistry, or closely related field

  • 4+ years of biopharmaceutical experience, with a technical background in mammalian cell culture, knowledge of cGMP regulations

  • Demonstrated proficiency with the qualification of the down-scale model, optimization of titer, and screening of media component

  • Demonstrated proficiency with the preparation of technical summary reports

  • Experience in preparation of research cell banks, general cell culture processes, expansion in shaker flasks and the evaluation of cell culture parameters

  • Strong science and mathematics background

  • Experience working in Microsoft Office or other common software tools

  • Hands-on experience in designing mammalian cell culture processes and operating bioreactors

  • Ability to travel up to 10%

  • Ability to work flex hours as needed on weekends to support cell culture process development

Preferred Qualifications

  • Experience in the optimization of cell culture harvest processes

  • Experience with Design of Experiment studies and software for process optimization

  • Experience with scale-up small-scale cell culture and transfer to a cGMP facility for full-scale manufacturing

  • Knowledge in bioreactor controller software, e.g. i-Control or BIOSTAT

  • Specialized training on current techniques, improvements, and Regulatory trends relevant to cell culture development.

  • Specialized training in statistical evaluation of data

  • Experience in the review of cGMP batch records

  • Experience with bioanalytical or purification techniques

  • Familiarity with mass spectroscopy evaluation of media components

  • Knowledge of SAS JMP

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

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Cell Culture Process Development Scientist

United Therapeutics Corporation