DESCRIPTION:
- 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 inprocess & 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 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.
REQUIREMENTS: Associates degree in Chemistry Pharmacology Pharmacy or related field and 5 years of experience in the job or related position. Prior experience to include:
- Testing finished products and raw materials.
- HPLC and GC.
- Using analytical techniques in support of product development.
- Current Good Manufacturing Practices (cGMP).
- Pharmacopeias (USP EP and JP) and basic regulatory requirements.
LOCATION: 9880 NW 25th Street Doral FL 33172
APPLY: Please reference job title: Analytical Scientist III Job Codeand send resume with cover letter to or mail to Recruitment at P&L Development LLC 200 Hicks Street Westbury NY 11590. No calls/faxes. EEO.