Analytical Scientist II

JOB QUALIFICATIONS:

• BS or MS in Chemistry with a minimum 3 years of pharmaceutical experience or equivalent combination of education and experience with testing Finished Products and Raw Materials
• Strong technical skills in HPLC and GC required
• Demonstrated use of the analytical techniques in support of product development activities
• Comprehensive knowledge of current Good Manufacturing Practices (cGMP), FDA Guidance, and ICH Guidelines
• Familiar with requirements of various pharmacopeias (USP, EP, JP) and basic regulatory requirements and applies knowledge appropriately to activities
• Demonstrated ability to work well in a fast-paced setting. Demonstrate ability to produce and interpret laboratory results
• Self-starter with a strong work ethic. Must be able to operate with minimal supervision
• Excellent written and verbal communication skills. Problem solving skills

POSITION RESPONSIBILITIES:

• Creates and executes new methods or procedures through appropriate research, development and validation stages with limited supervision
• Creates and executes project protocols and reports to support new product research and development as assigned by management with limited supervision
• Performs testing on raw material, in-process & finished product samples when applicable
• Documents all data in corresponding laboratory notebook and files documentation according to approved SOP and data integrity guidelines
• Supports pilot scale manufacturing to scale up of new manufacturing processes with limited supervision
• Responsible for analytical method validation/verification/transfer from R&D or client site to QC when assigned
• Interface with contract labs regarding QC sample handling and reporting
• Evaluate and interpret the test results and other related technical documentation
• Performs routine maintenance and troubleshooting of analytical equipment with limited supervision
• Document writing will include, but not limited to, preparation and review of SOPs, STMs, failure investigation and process deviation report, stability study protocol/report, method transfer protocol/report, method validation/verification protocol/report, instrument qualification protocol/report and analytical technical transfer protocol/report with the assistance of the supervisor when assigned
• Other duties may be assigned as deemed appropriate by management

PHYSICAL REQUIREMENTS:

• Employees are required to wear eye protection and lab coats while in the lab area
• Work safely and follow all OSHA regulations and company safety policies and procedures
• Ability to frequently lift and/or move up to 25 lb
• Ability to occasionally lift and/or move up to 35 lb
• Ability to regularly stand, sit and walk to perform task