About the role
Description
Job Summary: This position is primarily responsible for the laboratory testing of in-process, release and stability samples for commercial drug products.
Responsibilities
- Perform accurate and timely analysis of in-process, release, and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements
- Testing performed to include basic lab equipment and procedures, such as pH, Assay by HPLC, and Dissolution
- Document all laboratory testing and maintain accurate and legible notebooks and records
- Peer review of data, reports, and notebooks
- Education/Qualifications: BS Degree in Chemistry or related field
- AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
- BS Degree in non-science field and a minimum of 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
- Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
- Experience in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry)
- Excellent oral and written communication skills
- Strong organization and time management skills
- Demonstrated ability to work as part of a cross-functional team
Working knowledge of Microsoft Word and Excel
- Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)
- Work mainly performed in lab
- Travel < 5%