This individual is responsible for independently planning and performing routine tasks in the development laboratory and directly contributing to project teams.
Responsibilities include developing and transferring validation-ready analytical methods and manufacturing-ready formulations
location: Lexington, Kentucky
job type: Permanent
salary: $90,000 - 100,000 per year
work hours: 9 to 5
- Work in a safe manner in accordance with site procedures.
- Perform development stability testing and non-GMP production testing
- Maintain the laboratory in accordance with SOPs.
- Operate and maintain analytical instrumentation for development testing, including routine preventive maintenance and troubleshooting.
- Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports.
- Familiar with advanced analytical techniques for HPLC, UV/Vis, FTIR, GC, and Nasal Spray Testing and executes tasks without supervision or under the direction of a test method, standard operating procedure, or a protocol.
- Responsible for design and conduct of defined sets of experiments in support of a quality by design (QbD) process assisted by statistical design software
- Understanding of cGMPs and develop understanding EMEA regulations
- Excellent oral and written communication skills.
- Recommend and implement innovative approaches to problem solving.
- Utilize investigative skills for aberrant result laboratory investigations.
- Mentor Development Scientist I and II levels
- Other duties as assigned.
- Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules.
- Team player with well-developed interpersonal, organizational, and communication skills.
- Demonstrates proper social etiquette and self-control to others when dealing with stressful situations.
- Advanced technical experience and knowledge in analysis and development of pharmaceuticals
- Experience in development of validation-ready methods destined for QC in the pharmaceutical industry Minimum Qualifications:
- Relevant Technical Degree (years for guidance only) BS+6-12 yrs, MS+2-6 yrs, PhD+0-4 yrs
- Experience in FDA regulated environment
- Outstanding capabilities for adjusting priorities in response to changing conditions and schedules
- Experience with nasal spray drug product development and characterization is a plus
skills: Analytical Chemistry
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.