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
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
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
United Therapeutics Corporation