344585BR
May 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.
Should be a SME with strong IVIVC, pharmacokinetic and statistical knowledge and its application towards drug development. -Designs interpret and evaluate results of scientific experiments to establish IVIVC correlation of drug in-vivo absorption, distribution, metabolism and excretion with invitro experimental findings using Modeling & Simulations. Using pharmacokinetics, compiles data such as absorption and excretion rates in order to establish optimal and safe dosage rates. Using a physicochemical approach, attempts to compile various data such as absorption and excretion rates and drug agent half-life in order to establish pharmacokinetic profiles of molecular entities correlating with the in-vitro analytical findings as well as determining the prototype design optimization during the product development lifecycle. Work in close collaboration with multifunctional project team in designing project strategy, experimental invitro work. Provides input to operational and/or strategic discussions related to own technical knowledge. May bring new technique(s) into lab increasingly proficient at supporting multiple activities in parallel and contribute to document and interpret scientific/developmental experiments.

YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
• Assessment of relevance of in vitro dissolution/release characteristics on in vivo performance and selection of bio indicative method for product development
• IVIVC modeling in support of dissolution method development and setting up clinically relevant dissolution specification
• Bioequivalence risk assessment based on biopharmaceutics knowledge/IVIVC
• IVIVC assessment in support of formulation/Process change
• Evaluation of the results of bio studies and suggesting on formulation strategies
• Evaluation of RLD based on literature/experimental data and identify critical bioavailability attributes
• Preparation of BCS based Bio waivers report for regulatory submission
• Preparation of Bio waivers report based on modeling and simulation approach for regulatory submission
• Preparation of scientific report/justification in response to deficiency letter/post approval change
• Experienced in handling of novel dissolution (small volume dissolution, biphasic dissolution, precipitation study, USP-III/IV & permeation technology (Caco-2 cell permeability/IVPT study) for different dosage form (Complex oral solid/Injectable/Topical);
• Knowledge of statistical method to calculate dissolution similarity, population bioequivalence study, sample size and results of BE study.
• Additional: Good to have:
o knowledge or handling of novel dissolution (small volume dissolution, biphasic dissolution, precipitation study, USP-III/IV & permeation technology (Caco-2 cell permeability/IVPT study) for different dosage form (Complex oral solid/Injectable/Topical);
o Design / utilize state-of-art invitro methodology and interpret results; especially novel dissolution, bio relevant, discriminatory and multimedia, towards oral solid drug development. Be up to date with industry trends, embrace and adopt industry innovations on technology and advanced analytics, Regulation and guidelines.

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/M. Pharm in Biopharmaceutics/Pharmacology with 10-12 years of experience
• Expert knowledge of Biopharmaceutics and modeling and simulation approach
• Hands on experience in WinNonlin, Gastroplus, Simcyp, SAS, JMP etc
• Experience in all dosage form like OSD, Injectable, topical.
• Work in close collaboration with multifunctional project team in designing project strategy, experimental invitro work
• Should have strong analytical problem-solving skill, learning, adaptability and innovative experimental aptitude. Demonstrate good communication and presentation skills; and team connect & collaboration.
• Be up to date with scientific and industry trends, embrace and adopt industry innovations on modeling & technology and advanced analytics, Regulation and guidelines.

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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344585BR

Principal Scientist

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