343735BR
Apr 13, 2022
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.
• Support all the packaging development activities in close collaboration with formulation development & production sites till launch.
• Lead projects under minimal supervision, aiming the development of stable, registrable and cost-competitive products
• Design and manage packaging related studies, provide related scientific documentation/ technical justification. Assists in the preparation of and reviews the dossier.
• Willing to travel up to 20% of the time as per business need.

Your Key Responsibilities:
Your responsibilities include, but not limited to:

• Develop packaging configuration of pharmaceutical solid oral, injectable products with knowledge of ASAP, understanding of stability data interpretation and prepare specification of primary packaging components including CR and SF features in cost effective manner.
• Get involved in packaging campaigns as per in development and GMP area. Execute or consult on change controls for primary packaging components. Report and present scientific/technical results internally and contribute to publications, presentations and patents if applicable.
• Ensures own activities are conducted to high scientific standards and adhere to regulatory guidelines.
• Ensure accuracy of all documentation work related to packaging work order (PWO). Responsible for change controls & CAPAs.
• Collaborate at mathematical models/derivations to support bracketing and matrixing approaches for packaging systems, technical protocols, written experiments and technical reports to support container closure or materials development.
• Thorough knowledge of quality systems regulations (21 CFR 211) , and engineering design fundamentals for packaging testing (ASTM,ISTA).
• Actively participate in knowledge exchange. Train and coach associate scientists and technicians, temporary employees, and employees under training/education.
• Adherence to Sandoz standards, in particular quality (cGxP, data control), ethical, health, safety, environment (HSE), and information security (ISEC). • Support during internal and external audits and inspections

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:

• Bachelors with 8 years / Master with at least 6 years of work related experience or PhD with at least 3 years relevant experience.
• Broad theoretical and scientific knowledge in the area (e.g. packaging of injectable and solid oral pharmaceutical products for regulated markets)
• Proficient with laboratory, technical tools including application.
• Good knowledge of current Good Manufacturing Practices (cGMP)
• Presentation skills
• Advanced 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.
SANDOZ
Product Dev SZ
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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343735BR

Senior Scientist- Packaging Development

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