Senior Scientist, QbD & Data Science

Key Skills

JMP, Lean Six Sigma, Predictive Modeling, Simulation software, Statistical modeling

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.

• Lead projects under minimal supervision, aiming the development of stable, bioequivalent, registrable and competitive products. Design and manage studies, provide related scientific documentation. Assist in the preparation and review of the dossier.
• Provide excellence in predictive modelling, data analysis, & QbD principles to the site and the Sandoz global network. Drive the application of advanced and state-of-the-art in silico tools, predictive techniques, data analysis tools and methodologies under minimal supervision to improve process/product understanding, quality and compliance of the products, efficiency and capability of the processes and profitability to the organization.

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but are not limited to:

• Design, plan, perform/supervise and monitor all activities of assigned teams/ projects; handle several activities at a time; understand and meet project needs - Own and utilize complex tools/equipment or specialized facilities; ensure maintenance of infrastructure/equipment and required investments -
• Work according to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines; lead initiatives to ensure proactive compliance and continuous improvement; advise team members.
• Interpret results, evaluate data, and draw relevant conclusions; supervise project related scientific/technical activities, perform complex tasks. Review and approve raw data generated by others
• Write protocols, scientific reports, lab procedures or process-related SOPs; write scientific documents intended for external partners (e.g., other line units, authorities, external companies) and support generation of registration documents; interact with authorities where appropriate.
• Communicate, address and solve problems (e.g. deviations and unexpected results from experiments) within own and broader area of responsibility; communicate effectively across organizational interfaces; lead the transfer of know-how or procedures to other departments or external contractors, including troubleshooting and on-site training; may require up to 15% travel
• For technical development units: Develop complex methods (lab or plant); lead the optimization of project related scientific/technical activities or processes, co-ordinate local team(s); drive development and implementation of new technologies. For GMP related activities, ensure compliance to cGMP
• Provide scientific and technical guidance; perform information and literature searches; actively drive knowledge exchange. Develop, mentor and coach other scientific associates; present scientific/technical results internally and contribute to publications, presentations and patents
• Support the Scale up activities by providing the scale up factor/suggesting the appropriate methodology, Identifying the optimum process parameters for commercial batches based on trends observed in first few commercial batches
• Deploy state of the art in-silico tools in statistical modelling, predictive analytics, data mining, and machine learning to support in process ulation optimization and scale up.
• Support in drafting the data pertaining to Qbd in the development report, query response to the agency by using appropriate statistical methods/tools, stability data extrapolation/prediction of shelf life using appropriate methods
• Be up to date with industry trends, embrace and adopt industry innovations on data technology and advanced analytics.
• Develop new modelling/simulation tools and capabilities as needed. Collaborate with experimentalists to verify the models and work hand in hand with formulation experts and engineers to enable successful process transfers to production. Educate business users and leaders on how to interpret and use model output.
• Support non-project activities as needed, such as Op Ex, Lean Coach, GDP coordinator , maintenance and qualification of modelling and simulation related equipment/infrastructure etc
• Any other tasks as assigned by management

Diversity & Inclusion / EEO

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

Minimum Requirements

WHAT YOU’LL BRING TO THE ROLE::

• Masters or PhD in pharmaceutical sciences/chemical engineering/life sciences/computer science/ mathematics / statistics / any relevant discipline with hands on experience in predictive modelling and simulation.
• Master with at least 7 years of work related experience, or PhD with at least 3 years relevant experience
• Certified Six Sigma Black Belt
• Knowledge of various predictive Modelling and simulation techniques that are relevant in the pharmaceutical industry.
• Good knowledge and proficiency in QbD framework and application during drug development. Learning agility to work with new modelling and simulation tools available in the market/ customized advanced modelling platforms developed in house as per business need.
• Expertise in statistical modelling tools like JMP/Minitab/Design Expert
• Expertise in Process modelling and simulation tools including gPROMS, Rocky DEM, EDEM etc . Expertise in Other modelling and simulation tools like ASAP Prime, Dynochem
• Strong scientific and data driven decision making skills. Technical/scientific protocol and report writing skills
• Strong communication and presentation skills. Proven ability to manage and prioritize multiple projects.

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.