Senior Research and Development Director

24 hours ago


Hyderabad, Telangana, India Lee Pharma Limited Full time

Lee Pharma Limited is seeking an experienced Senior Research and Development Director to lead our team in the development of new pharmaceutical products.

As a key member of our organization, you will be responsible for managing multiple stakeholders at various levels within the company and outside, handling a variety of situations with ease.

You will demonstrate exceptional leadership skills, guiding our team towards achieving their goals and objectives.

A strong understanding of regulatory requirements for various markets including US, Japan, EU, China, and others is essential for this role.

You will develop processes considering ICH guidelines, GMP requirements, and post-approval changes while ensuring compliance with regulatory standards.

Problem-solving skills are crucial for controlling impurities, scale-up processes without deviations, achieving polymorph requirements, and particle size distribution.

Excellent negotiation and communication skills are necessary for dealing with ambiguity and providing clarity to team members and business partners.

Dedication to work is essential to achieve short-term and long-term proposed KRA without failure.

Strong collaboration skills and ability to work with cross-functional teams are required for this role.

Supporting other departments for plant validations, troubleshooting, regulatory affairs department (DMF fillings, DMF query responses, ANDA query responses, and laboratory audit preparation) is also part of the job.

You will perform experiments in laboratories for process developments, process optimization, identification of critical process parameters, yield improvements, and impurity preparations of API.

In addition, you will scale up processes in pilot plants for bulk drug and intermediates.

The estimated salary for this position is approximately $120,000 per annum, depending on location and experience.



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