Job Title: Extractable and Leachable (E&L) Scientist
Location: Hyderabad
Company: Aurobindo Pharma
Job Summary:
We are seeking a skilled and detail-oriented Extractable and Leachable (E&L) Scientist to join our team. The successful candidate will be responsible for conducting E&L studies on pharmaceutical and medical device products, ensuring compliance with industry standards and regulatory requirements.
Key Responsibilities:
•Conduct extractable and leachable studies on pharmaceutical packaging and medical devices.
•Develop and validate analytical methods for the detection and quantification of extractables and leachables.
•Perform sample preparation, extraction, and analysis using techniques such as GC-MS, LC-MS, ICP-MS, and other relevant analytical instruments.
•Interpret and report analytical data, ensuring accuracy and compliance with regulatory guidelines.
•Collaborate with cross-functional teams, including R&D, QA, and regulatory affairs, to ensure project success.
•Maintain and troubleshoot laboratory equipment to ensure optimal performance.
•Review technical reports and documentation for regulatory submissions.
•Stay updated with industry trends, guidelines, and best practices in E&L analysis
Qualifications:
•Bachelor’s or master’s degree in chemistry, Analytical Chemistry, or a related field.
•Minimum of 6-8 years of experience in extractable and leachable analysis within the pharmaceutical or medical device industry.
•Proficiency in analytical techniques such as GC-MS, LC-MS, ICP-MS, and related software.
•Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA, ISO) related to E&L studies.
•Excellent problem-solving skills and attention to detail.
•Effective communication skills and the ability to work collaboratively in a team environment.
•Experience with method development and validation is highly desirable.
Application Process:
To apply, please share your resume and a cover letter detailing your relevant experience and qualifications to [email protected] with Subject titled “Application for Scientist E and L”.
