Work independently in the identification and resolution of CMC method related issues.
Identify, evaluate, and implement novel and viable analytical technologies for characterization of polymers.
Coordinate routine testing of drug substance and product using contract service providers (CSP).
Support method improvements. This position reports to an Associate Director of Analytical Development and Quality Control.
- Conduct or coordinate analytical method development for release and stability of drug substance and drug product as well as raw materials.
Collaborate with scientists in Chemistry, and Manufacture groups to develop in-process control methods.
- Review raw data packages generated from routine testing of drug substance and drug product. Ensure data complies with cGMP and internal policies.
- Communicate issues related to routine testing with Contract Service Providers (CSP). Insure timelines are met.
- Conduct in-house change control for method related modifications and CSPs in the change control process.
- Write protocols and reports related to method validations and stability studies.
- Send reference materials and reagents to CSP and other sites that request then for conducting routine testing.
- Work with QA/QC to ensure compliance with company SOPs and guidelines; conduct work in compliance with GLP/GMP practices and regulations,
and safety and regulatory requirements.
- Assist in investigations and deviations occurring at CSPs by proposing experiments needed to find route cause of anomalous results.
- BS. in analytical chemistry or equivalent, with at least 8 year’s relevant laboratory experience.
- Extensive knowledge and hands-on experience on chromatographic and spectroscopic techniques.
- Expertise in physicochemical characterization of drug molecules, impurities and degradants.
- Working knowledge of GMP and Quality Control systems.
- Excellent protocol and report-writing skills with attention to detail.
We offer a comprehensive compensation package which We offer a comprehensive compensation package which includes Health Insurance and an
employer-matched 401(k) plan.
Qualified candidates should email a resume, including salary history and requirements, to