Principal Scientist- Formulation Development.

Sep 20, 2021

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.

Position Purpose

Lead and manage project/local network activities and contribute to strategic decisions; design, plan, perform, document and interpret scientific/developmental experiments or GMP testing or pilot plant processes for the preparation and timely delivery of drug sub-stances (DS), drug products (DP), processes or procedures within a multifunctional project team coordinated by a Project Leader; maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.

Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Design, plan, perform/supervise and monitor all activities of assigned teams/ projects; handle several activities at a time; understand and meet customer needs - Own and utilize complex tools/equipment or specialized facilities; ensure maintenance of infrastructure/equipment and required investments - Actively contribute to budget and resource forecast and grant preparation as needed. (Exposure to solid oral, solution, and complex injectables dosage form)
• 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 and ensure all own and team activities are aligned with overall drug development process
• Interpret results, evaluate data, draw relevant conclusions; supervise project related scientific/technical activities; perform complex tasks without having established procedures. 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 units: ensure compliance to cGMP
• For technology-focused role: 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 objectives setting, performance evaluations and development planning discussions with team members where appropriate; participate in recruitment process
• Support non-project activities as needed, such as Op Ex, GDP coordinator etc
• 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.

Minimum Requirements

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Product Dev SZ
Hyderabad, AP
Research & Development
Full Time

Principal Scientist- Formulation Development.

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