Job Details

Summary:

The primary purpose of this position is to perform routine and non-routine testing of in-process, finished product and stability samples to support product development and/or lifecycle management, to validate analytical methods, and to write and execute technical documents such as protocols and reports.

Responsibilities:

* Responsible for routine and non-routine testing of product samples to support new product development and/or management of existing product lifecycle.

* Responsible for the execution of analytical method validations in accordance with GMP, ICH, and other FDA guidelines.

* Must be able to process and analyze raw data and interpret results.

* Writes and reviews validation protocols and reports, methods, and other technical documents.

* Responsible for technical transfer of methods under validation from R&D to Quality Control.

* Responsible for documenting all lab work per cGMP and company standards and conduct peer review of analytical documentation.

* Operate basic and advanced instrumentation such as HPLC, GC, Dissolution apparatus, FTIR, UV-Vis, pH meter, and Karl Fischer.

* Troubleshoots and leads investigation of method validation failures and testing deviations.

Qualifications & Requirements:

Education:

* Bachelor of Science degree in Chemistry or related science.

Experience:

* 3+ years of experience in pharmaceutical industry or GMP laboratory.

* Experience in HPLC, Dissolution, GC, and compendial testing preferred.

* Strong written and documentation skills.

* Experience with Word Excel and common analytical instrumentation software such as Empower.

Travel: 0-10%