Key Responsibilities:**
- **Analytical Method Leadership:** Lead the development, optimization, and validation of complex analytical methods for the characterization of pharmaceutical raw materials, intermediates, and finished products.
- **Project Management:** Oversee multiple analytical development projects, managing timelines, resources, and budgets to ensure timely and successful completion.
- **Method Transfer:** Manage method transfer activities from R&D to Quality Control and manufacturing, ensuring smooth and effective transfer of validated methods.
- **Experimental Design and Execution:** Design and execute complex experiments to support analytical method development, validation, and troubleshooting. Analyze and interpret data to draw meaningful conclusions.
- **Technical Documentation:** Prepare and review comprehensive technical documents, including method development reports, validation protocols, method transfer documents, and regulatory submission documents.
- **Collaboration:** Work closely with cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Engineering and Supply chain to drive project success.
- **Compliance and Quality:** Ensure all laboratory activities comply with regulatory guidelines, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and internal quality standards.
- **Innovation and Continuous Improvement:** Stay abreast of industry trends, scientific advancements, and technological innovations to drive continuous improvement in analytical development practices.
- **Mentorship:** Mentor and guide junior scientists, fostering a collaborative and innovative work environment.
· Any other duties as assigned by supervisor.
#### **Qualifications:**
- **Education:**
- Senior Scientist: Master’s or Ph.D. in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related field.
- Principal Scientist: Ph.D. in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related field.
- **Experience:**
- Senior Scientist: 5 to 8 years of experience in analytical method development in the pharmaceutical industry, including project management and method transfer.
- Principal Scientist: > 10 years of experience in analytical method development in the pharmaceutical industry, with significant experience in project management and method transfer.
