Scientist II, R&D
Tom's River, NJ
Scientist II, R&D
The Scientist II, R&D position supports validation activities of analytical methods and method transfer from R&D to QC labs for new pharmaceutical products. Applying a solid understanding of Method Validation theories, practices and concepts, the incumbent works under the general direction of more senior R&D scientists to execute method validation, and method transfer activities. Ensure Standard Operating Procedures and protocols are maintained and applied.
- Under the general direction of the R&D Manager or a Senior Scientist, support validation activities of analytical methods and method transfer from R&D to QC labs as per the current SOPs, ICH and FDA guidelines.
- Support formulation and process development and regulatory submission activities.
- Use analytical techniques like HPLC/UHPLC, and GC using empower software, Karl Fisher, UV spectrophotometer etc., that is used in analytical development activities.
- Troubleshoot analytical challenges with minimum supervision.
- Compile, maintain, review and interpret analytical data.
- Assist with generating technical documents required for method validation and ANDA submissions such as recommendation and justification of specifications for finished products as per the current regulatory guidance.
- Author standard method of analysis.
- Author and review analytical test methods, reports and protocols.
- Conduct routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing of R&D and Engineering batches in-process testing which require critical levels of accuracy.
- Operate all laboratory analytical instrumentation including Empower 3 software, UPLC/HPLC, GC and UV/VIS, and other methodologies/instrumentation under minimum supervision, and perform troubleshooting and calibration of laboratory equipment as needed.
- Evaluate method and work with method development scientist to ensure minimum method validation and transfer challenges issues.
- Document all experimental work neatly and correctly in a lab notebook in accordance with Standard Operating Procedures.
- Review lab testing results and notebooks of peers to ensure accurate documentation.
- Maintain current knowledge of relevant other regulatory requirements related to method validation.
- Maintain quality checks on safety of the Lab, including biohazards and ensure maintenance of the facilities according to Good Laboratory Practices.
- Prepare data summary presentations, compile data and author technical and validation reports for ANDA submissions.
- Effectively interact with other scientists, project managers and colleagues from numerous functions.
- May be sought out by other teams and individuals to offer technical advice.
- Mentor junior scientists
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or similar degree and a minimum of 2-3 years of relevant experience in the pharmaceutical industry is required.
- Master’s degree with a minimum of 1 -2 years of experience is preferred, along with substantial experience and a proven record of achievement (Master’s degree will substitute for 2 years of experience).