Specialist– MS&T

Chemical Expertise

• Good understanding of Physico chemical buffer stability risk assessment, evaluation of corrosive agents as part of facility comparability assessment.
• Monitoring compliance alerts related to raw materials, (e.g. check ß-Lactam structure, EG/DEG)
• Experiences in preparation of Nitrosamine, Raw material risk assessments and declarations for residual solvents and Elemental Impurities.
• Experienced in performing Extractable and Leachable (E&L) risk assessments, Gathering E&L data from suppliers, coordinating E&L studies, and maintaining accountability for the site during audits.
• Preparation of Extractables and Leachables data for toxicological assessment

Validation Expertise    

• Create validation documentation including process validation protocol/reports, risk assessment, ongoing process verification (OPV) plans/ reports, cleaning

validation protocol/reports based on alignment with Site Validation Lead.

• Preparation of Transport Validation/Verification Protocols and conduct the necessary studies in coordination with cross functional teams. Collect the results and create the reports. Ensure all collected data is accurate and comprehensive and that protocols comply with regulatory requirements and organizational standards.
• Support in preparation and up dation of Hazard Analysis Critical Control Point (HACCP), Control strategies.
• Ensure the timely availability of technical documentation as per Novartis guidelines. Write Manufacturing Process Transfer Documents (Protocol, Report).
• Perform OPV/CPV evaluations, assess process performance and provide insight, recommendation and conclusion to the site MS&T team.

Essential Requirements

• Master's degree in biotechnology, Pharmacy, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.
• 5 to 9 years of Biologics Drug substance MS&T experience in Process, Cleaning Validations and Extractable and Leachables.
• Should be familiar with regulatory guidance on validation, product filing and post approval changes.
• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
• Expertise in reviewing and writing technical reports. Good communication, Presentation and Interpersonal skills.
• Proficiency in English (oral and written) is required, and Knowledge of German is an advantage.

Desirable Requirements

• Master's degree in biotechnology, Pharmacy, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.
• Proficiency in English (oral and written) is required, and Knowledge of German is an advantage.