348187BR
Jul 05, 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.

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 customer needs.
• Technical hands-on experience and expertise in handling dosage type expertise in Complex Injectables; such as Peptide based Injections, Nanoparticulate/microparticulate Suspensions, microsphere, Liposomes; support to drive & build inhouse injectable capabilities for complete physiochemical characterization; and also support global teams in project development.
• Subject Matter Expertise in defining and execution of complete characterization strategy for product development & sameness for complex injectable dosage type, identifying critical CQA for structural & physiochemical parameters; Experienced in Method development, Validation, and sameness package. Technical knowledge and experience in advanced-LC, HRMS, GC-MS/MS, IVRT & Dissolution testing, solid state physiochemical characterization etc. for complex dosage types. Knowledge on NMR and its application is a good to have.
• Identify, embrace, and adopt industry innovations on technology and advanced analytics, Regulation and Guidelines. Work in close collaboration with multifunctional project team in designing project strategy. Collaborate with internal CFTs, CROs, CMOs, and academic institutes to carry out complex injectable characterization; including designing experiments and reviewing reports and data.
• Interpret & evaluate results and draw conclusions; write & review characterization, analytical method, protocols and associated validation reports to ensure suitability for regulatory submissions. Manage several projects needs simultaneously while learning to prioritize and execute towards timelines. Bring new technique(s) into lab increasingly proficient at supporting multiple activities in parallel and contribute to document and interpret scientific/developmental experiments.
• Should have strong analytical problem-solving skill, learning, adaptability and innovative experimental aptitude. Demonstrate good communication and presentation skills; and team connect & collaboration. 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 .
• 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

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:

• PhD /Master of Science / Bachelor of Science (Chemistry or Pharmaceutical Analysis) Fluent in English (oral and written) Basic skills in local site-language, as required for the position Technical expert studies with PhD and 3 years relevant experience or Master of Science with 8 years of relevant experience.
• Technical hands-on experience and expertise in handling dosage type expertise in Complex Injectables; such as Peptide based Injections, Nanoparticulate/microparticulate Suspensions, microsphere, Liposomes. Experienced in Method development, Validation, and sameness package. Technical knowledge and experience in advanced-LC, HRMS, GC-MS/MS, IVRT & Dissolution testing, Solid State Characterization techniques etc. for complex dosage types. Knowledge on NMR and its application is a good to have.
• Awareness for safe handling of chemicals, potentially dangerous materials and equipment.
• Broad theoretical and scientific knowledge in the relevant area (e.g. manufacturing, analytical, pharmaceutical)
• Proficient with laboratory and/or technical tools. Good knowledge of software and computer tools.
• Good documentation skills . Good knowledge of current Good Manufacturing Practices (cGMP)
• Good 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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348187BR

Senior Scientist

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