Full-time, Permanent
Our client, a mid-sized pharmaceutical company is seeking qualified candidates for a full-time position in their Manufacturing department located in Research Triangle Park, NC. This candidate will be responsible for providing analytical support to R&D and Manufacturing functions. This position will develop and validate analytical test methods by following applicable regulatory requirements such as cGMPs and ICH guidelines.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Perform analytical chemistry independently and in collaboration with others to develop and validate analytical methodology, mainly stability-indicating HPLC methods, for testing small molecule drug candidates.
- Generate analytical data for new and existing drug substance, drug product and prototype formulations under development.
- Conduct stability studies to support the development of new drug products and drug substances.
- Review and provide analyses of data and documentation related to developing and validating testing methodology.
- Provide support to manage reference standards and the reference standard program.
- Perform and schedule routine maintenance and troubleshoot problems with analytical laboratory equipment.
- Conduct work in compliance with cGMP, safety and regulatory requirements.
MINIMUM EDUCATION & PREVIOUS EXPERIENCE REQUIRED:
- PhD in Analytical Chemistry with 1 year of experience in a GMP-regulated environment
- Experience with analytical methodology for both large and small molecules.
- The candidate should be comfortable working in a fast-paced environment and be flexible in supporting either Manufacturing or R&D analytical needs.
- Experience with HPLC and Empower software.
- This position requires a person who is a goal-oriented with excellent communication (written and oral) and organizational skills.
- This positon requires a person able to work effectively in teams.
- Strong organic chemistry background a plus.