Principal Scientist- Formulation Development. " >Principal Scientist- Formulation Development.

327992BR
Sep 20, 2021
India

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

WHAT YOU’LL BRING TO THE ROLE:
• Technical expert studies with PhD and 7 years relevant experience or Master of Science with 10 years of relevant experience. Fluent in English (oral and written)
• Awareness of safety regulations and for safe handling of chemicals and equipment.
• Thorough understanding of development activities and processes within own function and basic understanding of related functions
• Excellent theoretical and scientific knowledge in the relevant area (e.g. manufacturing, analytical, pharmaceutical)
• Strong scientific project management and leadership skills
• Good knowledge on relevant regulatory guidelines and good understanding of regulatory expectations
• Proficient with laboratory and/or technical tools.
• Good knowledge of software and computer tools. Good documentation skills Good knowledge of Good Manufacturing Practices (cGMP)
• Good presentation skills . Proficient scientific/technical writing 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.
Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
SANDOZ
Product Dev SZ
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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327992BR

Principal Scientist- Formulation Development.

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Source URL: https://www.novartis.com/careers/career-search/job-details/327992br/principal-scientist-formulation-development

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