About the Job:
Our team is responsible for creating drugs for use in clinical trials and scaling production of those drugs for the commercial market.
The Analytical Sciences department supports all assay needs, developing and qualifying assays to follow quality attributes of our products, supporting IND and BLA applications, assessing the capability of our processes by analyzing in-process samples, and developing release assays for transfer to Quality.
We are also instrumental in time-critical analysis support to Manufacturing as needed.
Key Responsibilities:
* Execute product testing to support Drug Substance and Drug Product process development teams
* Perform non-routine testing of in-process samples, and final product samples of key projects
* Conduct analytical tests using techniques such as HPLC, UPLC, CE, FTIR, and plate-based methods
* Document all test results accurately and in compliance with Good Laboratory Practices (GLP) and company SOPs
* Catalogue data/reports electronically in an accessible manner for inspections
Requirements:
* Strong understanding of GMP, GLP, and regulatory standards
* Familiar with protein chemistry/function and bioassays
* Experienced in cell culture techniques and protein expression/activity readout methods
* Excellent communication, collaboration and writing skills
* Proven data analysis, interpretation and scientific communication skills
* Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment
What We Offer:
A challenging and rewarding role in a dynamic team environment, opportunities for professional growth and development, and a collaborative culture that values innovation and excellence.
Join Our Team:
We are committed to attracting and retaining talented individuals who share our passion for delivering high-quality products and services. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.