Job Summary
The role involves the design and execution of experiments, as well as the establishment and validation of methodologies for drug substances and products. The successful candidate will utilize analytical tools such as SoftMax Pro and ensure compliance with relevant regulatory standards and current Good Manufacturing Practices (cGMP).
Responsibilities
- Design and perform experiments to support drug development.
- Establish and validate methods for both drug substances and products.
- Analyze experimental data using SoftMax Pro and other tools.
- Ensure compliance with regulatory standards and cGMP requirements.
- Effectively communicate research findings and results.
- Train and mentor junior team members.
- Deliver precise scientific results in a timely manner.
Qualifications
- Bachelor’s degree in chemistry, biochemistry, or biology with a minimum of five years of cGMP laboratory experience.
- Master’s degree in a relevant field with at least three years of experience, or a PhD with a minimum of one year of relevant experience.
- Must have authorization to work in the U.S. without any restrictions or sponsorship.
- Prior experience in contract research organizations (CRO) or contract development and manufacturing organizations (CDMO) is a plus.
- Experience in industrial method validation is desirable.
