Senior Scientist,ScaleUp & Tech 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. Responsible for development, scale up and tech transfer to internal and external manufacturing sites (CMOs). Provide process-engineering expertise and will use problem-solving techniques to resolve process difficulties, reduce waste, improve productivity and safety. CMO/CRO/STO finalization based on molecule nature and process understanding. Senior scientist will also provide technical support to site operations, maintenance and manufacturing personnel for supported processes. Additional job duties include investigating new technologies and their applications to manufacturing processes and assisting in development of products and processes for contract manufacturing projects. 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, MFR/BMR, HTSP/R, QRM, MFCs, stability protocols etc. 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. Provide technical expertise to the project execution team. 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, write and review protocols and reports for the following batches: Product characterization, Tech transfer, Exhibit/Registration and Validation.
• Develop innovative ideas and alternatives leading to lean, efficient and cost effective processes. 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).
• Material knowledge - data-driven procedure to facilitate materials selection and help accelerate pharmaceutical development studies. Should have understanding of Physical, chemical and surface morphology of the material in depth, Facilitates the risk assessment of any material in such a way that the drug product development and secondary process selection can be accelerated.
• Digital Initiatives - Digital Transformation is the process of upgrading or establishing a new way of carrying out critical process activities, as well as building new or adapting current trends, culture, and experiences, using digital technology to meet changing business and market requirements. Establish innovative solutions for verification and control of critical product attributes or critical process parameter in cooperation with other colleagues. Work to enable process to be simpler, better and faster using best practice frameworks and tools not limited to lean six sigma, agile, simulation and modeling etc.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements WHAT YOUxe2x80x99LL 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 Product development / scale up/ technology transfer activities.
• Ability to work on multiple projects concurrently and flexible to switch between projects if necessary.
• 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. Should have understanding of the material science to facilitate faster and robust development. An understanding of the parameters involved in scaling up of formulation processes.
• Good understanding of digital initiatives and PAT tools in pharmaceuticals.
• 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 multiple activities.
• Willingness to travel to CMOs/Plants based on business needs.

Why Sandoz 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while wexe2x80x99re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world. How will we do this We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent whats possible, when we collaborate with courage to aggressively and ambitiously tackle the worldxe2x80x99s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here at Sandoz! Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkDivision SANDOZ Business Unit Product Dev SZ Country India Work Location Hyderabad, AP Company/Legal Entity Nov Hltcr Shared Services IndFunctional Area Research & Development Job Type Full TimeEmployment Type Regular Shift Work NoEarly Talent No