Key Responsibilities:
This role encompasses a diverse array of bioanalytical processes aimed at supporting the production of bulk drug substances within a cGMP regulatory framework.
Essential Skills and Qualifications:
* Ensure all work adheres to current GMP, relevant regulatory standards, company policies, and standard operating procedures (SOPs)
* Review data from other analysts for accuracy and completeness
* Conduct gels/separations assays (CE-SDS/SDS-PAGE, iCIEF, PICO MCE, Western Blot) in compliance with cGMP practices
* Maintain laboratory reagents and supplies
* Prepare reagent aliquots and buffers for use in 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
* Develop new and update existing SOPs as needed
* Present bioanalytical data reports clearly and concisely to management
* Identify and implement lab process improvements, lean initiatives
Benefits: A dynamic work environment offering opportunities for professional growth and development.
Additional Information: This role requires strong analytical skills, attention to detail, and effective communication abilities. If you are a motivated individual seeking a challenging opportunity in a regulated industry, please apply.