Scientist I- Analytical R&D - Renaissance Lakewood LLC

The purpose of this role is to support validation activities of analytical methods and method transfer from R&D to QC labs for new pharmaceutical projects.  The incumbent will apply a working knowledge of method validation theories, practices and concepts while working under the direct supervision of senior R&D scientists to execute validation activities.  This role will ensure standard operating procedures and protocols are maintained and applied.

• Under the supervision of the R&D Supervisor/Manager or a Senior Scientist, this role supports validation activities of analytical methods and method transfer from R&D to QC laboratories as per the current SOPs, ICH and FDA guidelines.
• Conducts routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing in-process testing of R&D/engineering batches which requires critical levels of accuracy.
• Uses analytical techniques like HPLC/UPLC, GC using empower software, Karl Fisher, UV spectrophotometer, etc. that is used in analytical development activities.
• Authors standard methods of analysis. Authors and reviews analytical test methods, reports and protocols.
• Operates all laboratory analytical instrumentation and performs troubleshooting and calibrations of laboratory equipment as needed. Performs assigned various tasks which are needed to maintain the laboratory. Such tasks may include ordering lab supplies, calibrating instruments, cleaning glassware and Hazmat duties.
• Manages time effectively to complete assignments in an expected timeframe.
• Documents all experimental work neatly and correctly in a lab notebook in accordance with SOPs. Reviews lab testing results and notebooks to ensure accurate documentation.
• Ensures proper training before performing any tests and maintains an up-to-date training record related to all job functions and GXP requirements. Maintains current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Maintains quality checks on safety of the lab, including biohazards and ensures maintenance of the facilities according to GLP.
• Complies data and interprets any out of trend/specification against predetermined validation criteria and updates R&D Management accordingly.
• Effectively interacts with other scientist, project managers, and colleagues from numerous functions.
• Understands and complies with all Renaissance safety, environmental and quality practices and procedures as outline in SOPs and federal, state and local regulations. Ensure compliance to DEA regulations when using controlled substances.
• Flexibility in schedule is required.
• Other duties, as assigned.

Bachelor’s of Science Degree in Biochemistry or Chemistry
1-5 years of analytical laboratory experience in Pharmaceutical industry
Experience with method validation is required and method development is preferred.