Specialist- MS&T

Job Description

As a Specialist in Extractables and Leachables assessment at Novartis, your primary role involves collaborating closely with multiple functions such as MS&T, Supplier management, Regulatory, toxicology, Procurement, Quality, and Production to support Extractable and Leachable activities. You will focus on data collection, risk rating, assessments, and evaluation.Key Responsibilities:- Understand Extractable and Leachable (E&L) risk assessment for materials and update the Risk assessment based on supplier information.- Build a comprehensive material library supported by E&L test data.- Coordinate Extractables studies or product-specific leachable studies.- Prepare E&L Risk assessment, E&L testing Protocol, and Report.- Compile E&L data for assessment by Toxicologist.- Evaluate risk using decision matrix, Gap Analysis, and understanding of manufacturing materials.- Possess comprehensive knowledge of chemical and physical properties of MOC materials.- Define the original risk level, Mitigation factor, and Final risk level during the Risk Assessment process.- Expertise in Extractable studies methodologies, analytical strategies, and design.- Set AET (Analytical Evaluation Threshold) and SCT (Safety concern threshold) for extractables and leachables.- Understand E&L guidelines (SOPs, Pharmacopoeia, ICH standards).- Identify and assess the Worst-case material representative approach.- Collect material list and data from development centers and manufacturing sites.- Participate in E&L taskforce and network meetings, coordinating with various departments.Qualifications Required:- Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or related field.- Minimum 5 years of experience in MS&T or pharmaceutical manufacturing.- Familiarity with regulatory guidance on ICH Q3, Validation, Product filing, and Post-approval changes.- Project management experience in a cross-functional environment.- Expertise in reviewing and writing technical reports.- Good communication, presentation, and interpersonal skills.- Proficiency in English (oral and written).At Novartis, the commitment to diversity and inclusion is paramount, fostering an outstanding work environment that reflects the patients and communities served. If you are looking to be part of a mission-driven organization that aims to improve and extend peoples lives, Novartis offers a rewarding and challenging environment. Explore more about our culture and opportunities [here](https://www.novartis.com/about/strategy/people-and-culture). As a Specialist in Extractables and Leachables assessment at Novartis, your primary role involves collaborating closely with multiple functions such as MS&T, Supplier management, Regulatory, toxicology, Procurement, Quality, and Production to support Extractable and Leachable activities. You will focus on data collection, risk rating, assessments, and evaluation.Key Responsibilities:- Understand Extractable and Leachable (E&L) risk assessment for materials and update the Risk assessment based on supplier information.- Build a comprehensive material library supported by E&L test data.- Coordinate Extractables studies or product-specific leachable studies.- Prepare E&L Risk assessment, E&L testing Protocol, and Report.- Compile E&L data for assessment by Toxicologist.- Evaluate risk using decision matrix, Gap Analysis, and understanding of manufacturing materials.- Possess comprehensive knowledge of chemical and physical properties of MOC materials.- Define the original risk level, Mitigation factor, and Final risk level during the Risk Assessment process.- Expertise in Extractable studies methodologies, analytical strategies, and design.- Set AET (Analytical Evaluation Threshold) and SCT (Safety concern threshold) for extractables and leachables.- Understand E&L guidelines (SOPs, Pharmacopoeia, ICH standards).- Identify and assess the Worst-case material representative approach.- Collect material list and data from development centers and manufacturing sites.- Participate in E&L taskforce and network meetings, coordinating with various departments.Qualifications Required:- Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or related field.- Minimum 5 years of experience in MS&T or pharmaceutical manufacturing.- Familiarity with regulatory guidance on ICH Q3, Validation, Product filing, and Post-approval changes.- Project management experience in a cross-functional environment.- Expertise in reviewing and writing technical reports.- Good communication, presentation, and interpersonal skills.- Proficiency in English (oral and written).At Novartis, the commitment to diversity and inclusion is paramount, fostering an outstanding work environment that reflects the patients and communities served. If you are looking to be part of a mission-driven organization that aims to improve and e

Keyskills :
Data collectionAssessmentsEvaluationRisk assessmentRisk evaluationGap AnalysisProject trackingTechnical transfersPharmacyChemical EngineeringBiotechnologyChemistryValidationProject managementTechnical reportsCommunication skillsPresentatio