Job Description
JOB QUALIFICATIONS: - BS or MS in Chemistry with a minimum of 5+ 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, including theoretical understanding of technique
- 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
- Ability to successfully direct or manage various analytical projects and to contribute / facilitate team investigations
- Demonstrated ability to work well in a fast-paced setting. Demonstrate ability to take concepts and produce laboratory results
- Self-starter with a strong work ethic. Must be able to operate with minimal supervision
- Demonstrated ability to train and/or mentor new employees
- 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
- Creates and executes project protocols and reports to support new product research and development as assigned by management
- Performs testing on raw material, in-process, & finished good 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
- 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
- Document writing includes, 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 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
Equal Opportunity Employer
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Job Tags
Contract work,