Perform analytical chemistry testing to support the medical device and pharmaceutical industries. Provide technical expertise relating to chemistry testing and experimentation. Assist in building and maintaining technologies necessary to serve Analytical Chemistry clientele. Responsible for assisting in department compliance with applicable regulatory guidance documents and QA policies and directives. Responsible for interfacing with clients and building external scientific and client relationships.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Develop or supervise experimental designs to execute ISO 10993-18 testing on diverse medical devices
- Conduct routine and advanced analytical chemistry testing, utilizing instrumentation such as LC-MS, GC-MS, HPLC, and GC
- Provide scientific expertise for the interpretation and evaluation of results
- Prepare, review and approve GMP protocols and reports
- Review data generated by other Analytical Chemistry personnel
- Develop, validate, and document analytical methods
- Interface with clients
- Identify opportunities to improve workflow in lab
- Troubleshoot problems and provide and implement solutions to problems encountered
- Initiate and implement preventative and corrective actions
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION and/or EXPERIENCE:
- PhD in scientific field with minimum 3 years of experience or equivalent combination of education and experience
- Strong expertise and experience with instrumental spectroscopy and other analytical techniques including, method development, and structure elucidation
- Special consideration will be given to candidates with 10993-18 testing and mass spectroscopy elucidation experience.
- Knowledge in analytical chemistry bench-top techniques
- Knowledge of analytical instrumentation such as HPLC and GC with the ability to analyze and interpret chromatographic data
- Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint) and programs specific to lab instrumentation.
- Must be able to effectively communicate verbally and in writing with management, co-workers and clients. Read and comprehend work instructions/SOPs and protocols and write clear, concise reports.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and manipulate equations involving exponential and logarithmic functions. Must know basic statistical analysis and have the ability to perform statistical calculations. Must be able to use metric.
OTHER SKILLS AND ABILITIES:
- Ability to analyze, interpret and draw conclusions from data and exhibit problem solving and trouble shooting skills. Demonstrate significant attention to detail in testing and documentation practices.
For more information or to apply, please contact us at HR@iuvobioscience.com.