Impurities Scientist, Maryland

Job Description

We’re looking for a motivated and curious scientist to support testing and method development in our growing lab team. In this role, you’ll help ensure the quality and safety of our products by performing routine testing and contributing to important lab documentation. If you have a background in the sciences, some hands-on lab experience, and an interest in the biopharma world, this could be a great next step in your career.

Key Responsibilities:

Conduct routine and complex sample testing in the residual impurity lab within Analytical Sciences

Author and review Standard Operating Procedures (SOPs) to ensure compliance with regulatory standards and best practices

Perform ELISA and PCR testing for impurity analysis and characterization

Analyze and interpret complex data sets, preparing comprehensive reports for internal stakeholders and regulatory submissions

Collaborate with cross-functional teams to troubleshoot issues and optimize testing processes

Participate in method validation studies to ensure the accuracy and reliability of analytical procedures

Maintain detailed laboratory notebooks and electronic records in compliance with GMP standards

Contribute to the development and optimization of impurity profiles for drug substances and drug products

Assist in the preparation of regulatory documentation related to impurity testing and control strategies