CyberCoders Development Scientist in Lexington, Kentucky
Development Scientist Development Scientist - Skills Required - development scientist, Quality, Pharmaceutical, Chemistry, nasal spray, cGMP, Method Development, FDA, Small Molecule, Validation
If you are a Development Scientist with experience, please read on!
Founded in 2008, we are a specialty pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray drug products. We provide development and manufacturing services to our partners and to our clients for a wide variety of nasally delivered drug products and delivery systems. Our operations are compliant with FDA and EU current Good Manufacturing Practices (cGMPs), DEA regulations and are capable of supporting any stage of product development, from conceptual to commercial.
What You Will Be Doing
Provide expertise in chemistry and analytics related to our products
Perform method development, assay validation and characterization for multiple projects
Manage and participate on project teams
Lead nasal spray drug product formulation development projects
Perform data reviews, prepare reports and quality documents
Prepare analytical sections of regulatory filings
Identify and implement new techniques and instrumentation to expand internal capabilities
Author technical reports, regulatory submissions, SOPs, validation protocols, batch records and other cGMP documents
What You Need for this Position
--Degree in Chemistry or related field-- advanced degree preferred
3-5 years experience in analytical and drug product development activities regulated by FDA
Outstanding capabilities for adjusting priorities in response to changing conditions and schedules
Experience with nasal spray drug product development and characterization is a plus
Extensive technical experience in analysis and development of pharmaceuticals
Comprehensive understanding of small molecule chemistry
Demonstrated knowledge of modern analytical techniques, including HPLC. --Knowledge of nasal spray characterization a plus.--
Experience in development and validation of methods destined for QC (quality control) in the pharmaceutical industry
Understanding of current Good Manufacturing Practices (cGMPs)
Proven team player with well-developed interpersonal and mentoring skills, excellent organizational skills, communication skills, including written
documentation skills and presentation skills
What's In It for You
Great starting pay, good benefits, and ability to work with a fast growing organization!
So, if you are a Development Scientist with experience, please apply today!
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Development Scientist KY-Lexington JR12-1455501