What are the responsibilities and job description for the Scientist, Extractables & Leachables position at Stira Pharmaceuticals?
Company Description :
Stira Pharmaceuticals is a Sterile Injectable CDMO specializing in pharmaceutical product development and the manufacturing of small molecules and peptides. Our team of skilled scientists uses in-house technology platforms and extensive prior experience to develop challenging products. Stira Pharmaceuticals offers a range of services, including Analytical R&D, Preformation, Formulation Development, Manufacturing, and Regulatory Support.
Job Overview
Stira Pharmaceuticals, LLC, located in Fairfield, NJ, is seeking a full-time, on-site Analytical Scientist, Extractables & Leachables . In this role, you will be responsible for conducting analytical studies to identify and quantify chemical compounds that may migrate from packaging materials into a drug product. Your work will ensure the safety and quality of the final product by evaluating potential risks associated with these extractable and leachable compounds, all in alignment with regulatory guidelines within a cGMP environment.
Responsibilities
- Study Design & Execution : Develop and execute extractable and leachable (E&L) studies in compliance with established protocols and regulatory requirements.
- Method Development : Select appropriate extraction solvents and conditions, develop and validate methods, and perform stability testing under cGMP guidelines.
- Instrument Operation & Troubleshooting : Operate and troubleshoot LC-MS, GC-MS, ICP-MS, and other relevant analytical instrumentation for E&L testing.
- Data Analysis : Identify and characterize extractable and leachable compounds, interpret their toxicological significance, and evaluate potential risk to the drug product.
- Documentation & Reporting : Prepare comprehensive reports summarizing study results and conclusions, maintaining data integrity and adherence to GMP guidelines.
- Regulatory Compliance : Stay updated with relevant regulatory agency (FDA, EMA) expectations for E&L studies and collaborate with Regulatory Affairs teams to address any concerns.
- Cross-Functional Collaboration : Work closely with R&D, Quality Control, and Regulatory Affairs to ensure product development and regulatory submission requirements are met.
- Continuous Improvement & Mentorship : Stay current with advancements in analytical techniques, troubleshoot analytical issues, and train junior staff in best practices.
Qualifications :
