Summary/Purpose of Job
To ensure availability of appropriate and accurate analytical methods and providing testing for small molecule pharmaceuticals.
Essential Duties/Responsibilities
Core Responsibilities:
- Timely development of analytical methods for in-process and release testing at various stages of product life cycle
- Providing technical and analytical assistance/solution in impurity identification efforts
- Assessment of test methods provided by clients
- Assessment of analytical efforts and their cost on new (potential) projects.
- Ensuring proper record-keeping, full traceability, and efficient communication of analytical findings, observations and results across organization
- Managing a library of analytical methods
Support of the Quality Unit:
- Supporting QC activities, as needed
- Providing analytical development reports to QC
- Participation in development of analytical validation/qualification/degradation/stability studies protocols and reports (including analytical test methods used in cleaning validation/verification)
- Technical assistance in establishment of specifications for Active PharmaceuticalIngredients
- Providing technical coaching to colleagues
- Providing assistance during cGMP audits and inspections
Services:
- Performing and/or providing assistance for analytical testing for R&D and cGMP applications, as needed
- Providing training to chemists on developed methods and setting the methods on R&D equipment
- Providing training on equipment use
Equipment:
- Troubleshooting of all analytical equipment in the facility
Other:
- Helping create a positive work environment
- Other reasonable duties may be assigned as necessary
Qualification Requirements
- Advanced degree in chemistry
- 2 - 5 years’ experience in analytical development, validation and testing in QC environment for various compounds
- Strong analytical skills
- Hands-on experience with a broad range of analytical instrumentation, including HPLC, GC, MS, FTIR, UV-Vis Spectrophotometry and new analytical techniques
- Strong organizational skills and ability to multitask
- Knowledge of regulatory requirements, cGMP and ICH guidelines
- Strong communication skills
Physical Demands/Work Environment
- Ability to safely handle hazardous materials
- Ability to lift 50 pounds
- Ability to bend to reach floor level
