Job Description

About the role

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our \'new\' Sandoz!

Your Key Responsibilities:

1. Bioequivalence risk assessment based on biopharmaceutics knowledge/IVIVC. Evaluation of RLD based on literature/experimental data and identify critical bioavailability attributes. Expertise in handling GastroPlus, Phoenix WinNonlin, Simcyp and DDD Plus software in performing the in-silico simulations to support the generic formulation development.

2. Expertise in Pharmacokinetic modeling and establishment of PBPK and IVIVC models in support of dissolution method development and setting up clinically relevant dissolution specification.

3. Plan, guide and collaborate the associates for the in vitro experimentations such as solubility, IDR and development of biorelevant and discriminatory dissolution methods. Evaluation of the results of bio studies and suggesting on formulation strategies.

4. Review of protocols, lab procedures and raw data from various in vitro experiments. Provide documentation and draw relevant conclusions independently and design next experiments; supervise project related scientific/technical activities.

5. 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 forms

6. Enable formulation development team toward critical BE decisions, prototype selection; validation/registration batch selection and post filing deficiency support. Knowledge of statistical method to calculate dissolution similarity, population bioequivalence study, sample size and results of BE study.

7. Preparation of Bio waivers report based on modeling and simulation approach for regulatory submission.

8. 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.

Role Requirements

What you\'ll bring to the role:
Essential Req\xc2\xb7

Experience of 12-15 years in Biopharmaceutics R&D, IVIVC from generic pharmaceutical industry.
M Pharm (Biopharmaceutics, Pharmaceutics, Pharmaceutical Technology, Pharmacology); Ph D (Pharmaceutical Sciences; Pharmaceutical Technology)
Attributes required of the job e.g. the ability to work independently; ability to work in a team; shows initiative; able to work with all levels of staff.
Strong written and oral communication skills
You\'ll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Functional Area

Research & Development

Division

SANDOZ

Business Unit

NON-NVS TSA SANDOZ GLOBAL DEVELOPMENT

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Novartis