Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Scientist - Process Scale up Tech Transfer
Job Description
Position Purpose
• Provide process engineering expertise to recommend the laboratory experiments that will eventually lead to seamless process scale-up operation.
• Lead projects under minimal supervision to ensure smooth technology transfer to internal and external manufacturing sites.
• Keep track of logistical arrangements for upcoming and ongoing technology transfers at manufacturing sites that includes, but not limited to maintaining records pertaining to the timelines for execution of different Technology transfer batches, availability log for raw materials and relevant documentation.
• Actively collaborates with scientists at development center and the counterparts at manufacturing site and acts as a sort of interface between development center and manufacturing site
• Recommend opportunities for improvement with plant efficiency and risk mitigation as main objectives and document the summary.
• Shall own and design the strategy to troubleshoot the issues arising during scale up operations. Assists in the preparation of and reviews the reports and protocol that form part of technology transfer dossier for example, but not limited to, MFCs, stability protocols etc.
Position Purpose
• Provide process engineering expertise to recommend the laboratory experiments that will eventually lead to seamless process scale-up operation.
• Lead projects under minimal supervision to ensure smooth technology transfer to internal and external manufacturing sites.
• Keep track of logistical arrangements for upcoming and ongoing technology transfers at manufacturing sites that includes, but not limited to maintaining records pertaining to the timelines for execution of different Technology transfer batches, availability log for raw materials and relevant documentation.
• Actively collaborates with scientists at development center and the counterparts at manufacturing site and acts as a sort of interface between development center and manufacturing site
• Recommend opportunities for improvement with plant efficiency and risk mitigation as main objectives and document the summary.
• Shall own and design the strategy to troubleshoot the issues arising during scale up operations. Assists in the preparation of and reviews the reports and protocol that form part of technology transfer dossier for example, but not limited to, MFCs, stability protocols etc.
Major Accountabilities
• Provides process engineering expertise to technology transfer of projects to internal and external manufacturing locations.
• Perform process engineering analysis to determine cycle time, equipment fit, technologies required, scale up risk etc.
• Perform engineering analysis of process execution, recommend opportunities for improvement, process modeling, process flow diagrams, compatibility assessments, risk management etc.
• Support process validation and commercialization activities for process transfers to external suppliers.
• Develop innovative ideas and alternatives leading to lean, efficient and cost effective processes.
• Provide technical expertise to the project execution team.
• Participate in Hazard and Operability (HAZOP) studies.
• Design, plan and perform/supervise scientific experiments and contribute to project related scientific/technical activities under minimal supervision (e.g., interpret and report results, generate and evaluate data, draw relevant conclusions, optimize existing methods/processes).
• Establish innovative solutions for verification and control of critical product attributes or critical process parameter in cooperation with other colleagues.
• If assigned this task, maintenance of infrastructure/equipment and required investments (e.g. system ownership).
• Report and present scientific/technical results internally and contribute to publications, presentations and patents.
• Actively participate in knowledge exchange. Train and coach associate scientists and technicians, temporary employees, and employees under training/education.
• Adherence to Sandoz standards, in particular quality (cGxP, data control), ethical, health, safety, environment (HSE), and information security (ISEC).
• Support during internal and external audits and inspections
• Provides process engineering expertise to technology transfer of projects to internal and external manufacturing locations.
• Perform process engineering analysis to determine cycle time, equipment fit, technologies required, scale up risk etc.
• Perform engineering analysis of process execution, recommend opportunities for improvement, process modeling, process flow diagrams, compatibility assessments, risk management etc.
• Support process validation and commercialization activities for process transfers to external suppliers.
• Develop innovative ideas and alternatives leading to lean, efficient and cost effective processes.
• Provide technical expertise to the project execution team.
• Participate in Hazard and Operability (HAZOP) studies.
• Design, plan and perform/supervise scientific experiments and contribute to project related scientific/technical activities under minimal supervision (e.g., interpret and report results, generate and evaluate data, draw relevant conclusions, optimize existing methods/processes).
• Establish innovative solutions for verification and control of critical product attributes or critical process parameter in cooperation with other colleagues.
• If assigned this task, maintenance of infrastructure/equipment and required investments (e.g. system ownership).
• Report and present scientific/technical results internally and contribute to publications, presentations and patents.
• Actively participate in knowledge exchange. Train and coach associate scientists and technicians, temporary employees, and employees under training/education.
• Adherence to Sandoz standards, in particular quality (cGxP, data control), ethical, health, safety, environment (HSE), and information security (ISEC).
• Support during internal and external audits and inspections
Candidate Profile
• Masters in chemical engineering/ pharmacy with at least 8 years of work related experience, or PhD with at least 4 years relevant experience
• Fluent in English (written and spoken).
• Masters in chemical engineering/ pharmacy with at least 8 years of work related experience, or PhD with at least 4 years relevant experience
• Experience in scale up/ technology transfer activities.
• Understanding of project management skills and should have excellent planning acumens.
• Strong scientific skills allowing the drawing of accurate assump-tions from limited data to assess the next step in scale up batches.
• An understanding of experiment and validation design and the requirements when documenting protocols for these exercises
• An understanding of the parameters involved in scaling up of formulation processes
• Effective analytical and problem solving skills.
• Technical/scientific protocol and report writing skills
• Practical Knowledge of statistical approaches in product formulation optimization shall be appreciated
• Strong communication and presentation skills.
• Effective collaboration and interpersonal skills
• Proven ability to manage and prioritize multi
• Masters in chemical engineering/ pharmacy with at least 8 years of work related experience, or PhD with at least 4 years relevant experience
• Fluent in English (written and spoken).
• Masters in chemical engineering/ pharmacy with at least 8 years of work related experience, or PhD with at least 4 years relevant experience
• Experience in scale up/ technology transfer activities.
• Understanding of project management skills and should have excellent planning acumens.
• Strong scientific skills allowing the drawing of accurate assump-tions from limited data to assess the next step in scale up batches.
• An understanding of experiment and validation design and the requirements when documenting protocols for these exercises
• An understanding of the parameters involved in scaling up of formulation processes
• Effective analytical and problem solving skills.
• Technical/scientific protocol and report writing skills
• Practical Knowledge of statistical approaches in product formulation optimization shall be appreciated
• Strong communication and presentation skills.
• Effective collaboration and interpersonal skills
• Proven ability to manage and prioritize multi
Additional Information
Experience : 5+
Qualification : M.Pharm, Ph.D
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th March, 2018
Experience : 5+
Qualification : M.Pharm, Ph.D
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th March, 2018
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