Job Descriptions

In your new role, you will:

• Complete writeups on time and participate in the review of team analytical work. Conduct validation testing for key projects in the Bioassay group.
• Generate validation documentation, update SOPs, oversee the progression of key validation projects within the Bioassay group, JMP analysis, generate toxin trends, qualification of critical reagents and perform lab duty tasks as required.
• CBPA analysis of release, stability and investigational analytical activities.
• Support and execute Method Transfer and Validation activities associated with key biological drug product projects.
• Compiling and review of Laboratory documentation (e.g. SOPs, methods, validation documentation etc.).
• Support regulatory inspections as required.
• Perform lab duty tasks to maintain a high standard of housekeeping within the laboratory.
• Drive Root Cause Analysis investigations.
• Support and lead Laboratory projects to ensure timelines are met successfully.
• Manage group activities as required and lead projects to ensure completion.
• Participate at meetings and provide input to key projects and improvements within the group.
• Adhere to and support all EHS procedures and policies.

So does this role sound exciting? then read on.....

To succeed in this role, you will have the following Education and Experience:

• You will have a 3rd level qualification in a relevant science discipline with master or PHD preferred.
• Knowledge of biologics manufacturing, bioassays, biochemistry, biostatistics and experience within a GMP testing laboratory.
• A clear understanding of working within a regulated environment.
• Excellent communication and presentations skills, both written and oral.
• Strong analytical skills with the ability to plan and schedule workloads.
• Drive, high energy, maturity, and ability to work under pressure and deliver results

Skills

• Presentation Skills
• Analytical Skills
• Excellent written and verbal communication skills

Experience

• 1 year