Bioassay Scientist

We are seeking an experienced Bioassay Scientist with a strong background in developing and validating cell-based assays for pharmaceuticals. The successful candidate will work in our laboratory and oversee stability studies and batch release for GMP standards.
Responsibilities:

• Develop and validate cell-based assays for pharmaceuticals
• Oversee stability studies and batch release for GMP standards
• Ensure compliance with regulatory requirements, including ICH guidelines (ICH Q2 R2) and good documentation practices (GDP)
• Use Softmax Pro and Flow Cytometry to analyze and interpret data
• Work collaboratively with other scientists to design and execute experiments
• Troubleshoot technical issues and provide solutions as needed

Requirements:

• Several years of experience in a laboratory position developing and validating cell-based assays for pharmaceuticals
• In-depth knowledge of cell-based potency assays
• Understanding of method validation in accordance to ICH guidelines (ICH Q2 R2)
• Experience working in a GMP regulatory laboratory
• Familiarity with good documentation practices (GDP) and data integrity
• Proficiency in Softmax Pro and Flow Cytometry
• Excellent written and verbal communication skills
• Strong problem-solving and analytical skills

If you are a dedicated and experienced Bioassay Scientist looking for a challenging opportunity, please apply with your CV and cover letter. We offer a competitive salary and benefits package, as well as opportunities for growth and advancement within our organization.