20835026 Senior Scientist-Process Scale up transfer

Job Description

1886! We have more than 130 years of experience treating patients.Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.YOUR KEY RESPONSIBILITIES:Your responsibilities include, but are not limited to: Provides process-engineering expertise to technology transfer of projects to internal and external manufacturing locations. 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. 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. 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 interpret and report results, generate and evaluate data, draw relevant conclusions, optimize existing methods/processes). Provide technical expertise to the project execution team. Participate in Hazard and Operability (HAZOP) studies. 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 inspectionsMinimum requirements WHAT YOU LL BRING TO THE ROLE: 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 assumptions 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 Why consider Sandoz Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.Imagine what you could do at Sandoz!Commitment to Diversity & Inclusion:Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.,

Keyskills :
researchvalidationdocumentationapihplcprocess flowflow diagramsraw materialsreport writingwriting skillsexternal auditcost effectiverisk managementproblem solvingprocess modelingproject execution