Job Description Summary

The purpose of the Specialist role is to work collaboratively with Biologics Site MS&T team and multifunctional technical operations teams in Large molecules platform. The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities. Maintain the oversight on Process, Transport validations, Extractable and Leachables activities, preparation and up dation of Risk assessments for Validation activities.

 

Job Description

• 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
• 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.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and accommodation 
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

 

Skills Desired

Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process and Cleaning Validation, Process Control, Quality Control, Regulatory Compliance, Resilience and Risk Management