Job Summary
In this role, you will perform a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment.
Key Responsibilities:
* Ensure all work is in compliance with current GMP, required regulatory standards, company policies, and standard operating procedures (SOPs)
* Review data from other analysts for accuracy and completeness
* Perform bioassays in line with cGMP practices
* Sub-culture mammalian cell lines and perform cell counts
* Maintain laboratory reagents and supplies
* Prepare reagent aliquots and media for use in cell-based assays
* Maintain equipment in the laboratory
* Conduct laboratory investigations and generate reports in response to invalid assays, deviations, OOS/OOT
* Initiate and complete CAPAs in accordance with site procedures
* Write new and update current SOPs as needed
* Present bioanalytical data reports clearly and concisely to management
* Identify and implement lab process improvements and lean initiatives
This role may be suitable for individuals who have:
* Current or prior experience working with Bioassays
* A proven ability to work independently or as part of a team
* Strong trouble-shooting and problem-solving skills
* Strong attention to detail and excellent written and oral communication skills
* Experience working with molecular biology and cell biology techniques such as ELISA, Bioassay, and mammalian cell culture
To be considered for this opportunity, applicants must hold a BS/BA in Life Sciences or a related field, or an equivalent combination of education and experience, with 2+ years of experience working in a regulated testing environment. Previous experience working in a Biotech environment is highly advantageous.