- Hyderabad, India
- Closing date
- Mar 23, 2023
- Health Sciences, Drug Development
- Position Type
- Full Time
- Organization Type
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.
Design, plan, coordinate and execute product related scientific/technical development activities independently with QbD implementation for global regulated markets. Scale up and technology transfer of products to manufacturing sites and stage wise documentations. Support in equipment qualification and maintenance of operational aspects in lab as assigned.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Evaluation of literature/patents and to design formulation strategies for the products under development.
• Design, plan and execute pre-formulation studies, development batches and document scientific experiments/plant activities under minimal supervision. Planning of stability studies and reviewing of development and stability data. Take over responsibility for and utilize special tools/equipment or specialized facilities as an expert to develop robust product. Write protocols, scientific reports or lab procedures based on templates or SOPs under minimal supervision. Support in maintenance and qualification of instruments/equipment as assigned.
• To compile raw data, evaluate and interpret results; propose and provide input for the design of next experiments. Review and verify raw data generated by others; approval of test/experiments performed by others.
• 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.
• Recognize, communicate, address and solve problems (e.g. deviations and unexpected results from experiments) within own and broader area of responsibility; actively transfer know-how or procedures to other departments or external contractors, including troubleshooting and on-site training. Proactively identify conflict situations and contribute with empathy to solutions.
• For technical development units: Develop new methods or optimize existing methods (lab or plant); contribute to development and implementation of new technologies. For GMP units: ensure compliance to cGMP.
• Coordination with cross-functional teams like analytical department, BD, Sourcing and project management for timely execution of project work under supervision.
• Train and coach technicians, temporary employees and employees under training/education. Support non-project activities, as needed, such as Op Ex, GDP coordinator etc.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
WHAT YOU’LL BRING TO THE ROLE:
• Masters in pharmacy with 2-4 years of relevant experience in formulation development for regulated markets with good theoretical and scientific knowledge in the relevant area (e.g. manufacturing, pharmaceutical and understanding of analytical results) with effluent English (oral and written.
• Adequate understanding of development processes in relevant area.
• Proficient with laboratory and/or technical tools. Good knowledge of software and computer tools.
• Good documentation, presentation and advanced scientific/technical writing skills.
• Knowledge of current Good Manufacturing Practices (cGMP).
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.
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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