Manager, QC Analytical Chemistry

The primary responsibilities of the Manager, QC Analytical Chemistry will involve analytical methods development and validation, managing 7-10 QC analytical chemists, release testing, and general QC and analytical chemistry tasks. A Ph.D. or a masters degree in analytical chemistry is preferred with experience working in cGMP Quality Control and analytical chemistry is a requirement.

Responsibilities:

Perform analytical method development for development project as well as troubleshoot existing methods as needed
Run the testing necessary for analytical methods validation and write the associated reports in accordance with cGMP guidelines
Manage the testing schedule of the quality control analytical equipment and staff associated with manufacturing schedule
Work closely with chemists and management to ensure projects are completed in a timely fashion
Perform release testing of raw materials, intermediates, and finished products in accordance with cGMP guidelines
Maintain laboratory equipment and work areas in good working condition
Perform assigned calibrations for equipment in the laboratory
Recognize and report Out of Specification results, out of trend results and deviations to Quality Assurance
Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating procedures
Proactively revises and authors new SOPs and study documentation.
Observes all safety procedures and regulations
May perform other duties as assigned.

Education and/or Experience

Ph.D. or Masters Degree in Organic or Analytical Chemistry is preferred, min BS in Chemistry
3-5 years quality control and analytical chemistry experience doing method development and validations in a cGMP Manufacturing environment
Extensive experience running analytical equipment including HPLC, GC, FTIR, KF
High degree of oral and written communication skills
Experience with Microsoft Word, Excel