4064 Cell Culture Associate
Position and Candidate Description:
The contractor will support the tech transfer and commercial production of monoclonal antibody processes.
Tech transfer activities will support the execution of engineering runs and process performance qualification runs at the facility.
Commercial production activities will support process monitoring to ensure the commercial process remains in a state of control.
Candidate must be familiar with mammalian cell culture processes for the production of monoclonal antibodies.
Hands on experience with cell culture processes is a plus but not a requirement.
Candidate responsibilities may include the following:
Configuring data systems to compile and organize process data.
Compliance checking protocols and reports to ensure data integrity standards are maintained.
Compliance checking manufacturing specifications against process design requirements.
Compliance checking batch records and historical data between manufacturing sites.
Performing statistical analysis to identify process improvement opportunities.
Authoring process validation protocols, reports, and data packages.
Knowledge with OSisoft, Inc., PI Server and client tools, Oracle server and client tools, Microsoft Visual Studio, Visual Basic, SQL, SAS JMP and associated scripting language.
To be eligible for this position, contractor must have completed BS or higher degree at an accredited college or university and proficiency in data acquisition and programing techniques, and strong technical writing and oral communication skills.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.