Sandoz MSc Biotech Expert Position Available, Apply Now
Are you a seasoned expert in Extractables and Leachables (E&L) with a Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or a related science stream and a minimum of 8 years of experience in MS&T or pharmaceutical manufacturing? Sandoz is seeking a highly knowledgeable Expert – Extractables & Leachables to join our team in India. If you possess comprehensive knowledge of E&L risk assessment, testing methodologies, and regulatory guidelines, apply now to play a critical role in ensuring the safety and quality of our pharmaceutical products!
Job ID: REQ-10044715
Posted Date: 20/03/2025
Location: India
Job Description
Key Responsibilities:
- Conduct E&L risk assessments based on supplier data, determine risk levels, and maintain documentation.
- Build and manage a material library with supporting E&L data; coordinate extractables and leachables studies as needed.
- Prepare E&L risk assessments, testing protocols, and reports; communicate findings to Toxicologists.
- Apply risk evaluation tools (decision matrix, gap analysis) and understand manufacturing material impact.
- Evaluate chemical/physical properties and leaching behavior of Materials of Construction (MOC); determine initial, mitigated, and final risk levels.
- Design and interpret extractables studies; set AET and SCT thresholds for detected substances.
- Apply relevant E&L guidelines (SOPs, ICH, USP 665/1665); understand regulatory expectations.
- Use worst-case material approaches; gather material data from development and manufacturing sites.
- Participate in E&L taskforces and collaborate with Development, Supply Management, QC, and Production teams.
What you’ll bring to the role:
Essential Requirements:
- Prepare and manage process and cleaning validation documents, including protocols, reports, and change evaluations for new products and life cycle activities.
- Keep project tracking tools updated per the project plan.
- Collaborate with development teams during tech transfers and launches to ensure effective knowledge transfer, risk control, and commercial process readiness.
- Perform thorough data integrity checks to ensure accuracy and completeness before analysis or reporting.
- Coordinate document reviews with MS&T, QA, QC, and Regulatory CMC as needed.
- Manage the preparation, approval, and maintenance of GxP documentation throughout its lifecycle
Experience:
- Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams. A Master’s degree (MSc/MS) or equivalent experience is desirable.
- Minimum of 8 years of relevant experience in Manufacturing Science & Technology (MS&T) or in the manufacturing of pharmaceutical Drug Substance and Drug Product for both Small and Large molecules.
- Should possess a strong familiarity with regulatory guidance documents, including ICH Q3 guidelines, Validation principles, Product filing requirements, and Post-approval change management processes.
- Proven project management experience within a cross-functional environment, including multi-site projects, technical development initiatives, and collaborations with other functional areas.
- Expertise in the critical review and professional writing of technical reports.
- Excellent communication, presentation, and interpersonal skills.
- Proficiency in both oral and written English is a mandatory requirement.
