Preclinical Scientist

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centers, manufacturing facilities or a commercial presence in 66 countries. 

For four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Summary
We are seeking a dynamic and experienced person for the role of ‘Scientist’ in Pre-Clinical team to support the nonclinical development of complex generics and differentiated products from strategy/development stage through the product approval for all vertical domains and all geographies.

Roles & Responsibilities

• You will be responsible for supporting the Lead/Expert for devising preclinical development strategy and product development through literature search and assimilation, continuous support with in-vivo evaluation of the products during development stage of products. 
• You will be supporting the execution of in-vitro and in-vivo pharmacodynamics, pharmacokinetics and toxicological studies at contract research organizations for API, complex generics and differentiated products. The activities would include verification of the test article characterization data, review of preclinical study protocols/data/reports, compilation of study findings for internal discussion and decision making, review the in-life and terminal parameter data and statistical analysis of biological data as required.
• You will be assisting in identification and selection of contract research organization (CRO) for all preclinical studies including Pharmacokinetic-Pharmacodynamic (PK/PD), Toxicology biomarkers for both API and Global Generics during nonclinical bio studies for all the geographies United States/Europe/Canada/ all Emerging markets.
• You will be performing Toxicological Risk Assessment of excipients/ intermediates/ impurities/ extractables/leachables in order to support generic/differentiated drug manufacture, development and marketing.
• You will be supporting the Lead/Expert in making human health hazard assessments of chemicals by deriving health based exposure limits.
• You will be performing Environmental Risk Assessment for EU and US generic and NDA filings
• You will be supporting the Lead/Expert in executing impurity qualification studies. Coordinate with CRO for timely execution while ensuring regulatory compliance and data integrity.
• You will be supporting the Lead/Expert to handle the queries by problem solving approach, literature collection and providing justification in time for any pharmacokinetics/efficacy/toxicity related deficiencies raised by the regulatory agencies.

Educational qualification: M.V.Sc. / M.Pharm/ M.Sc (Pharmacokinetics/Pharmacology/ Toxicology)

Minimum work experience: 5 years in Pharma Industry

Skills & attributes:
Technical Skills

• Experience on Pre-Clinical Development Strategy, and Pre-Clinical trial methodology.
• Broad understanding of Pharmacokinetics, Pharmacodynamics, Toxicology, Analytical, Bioassay/Bioanalytical.
• Knowledge in Regulatory requirements of United States Food Drug Administration, European Medicines Evaluation Agency, and Good Laboratory Practices.
• Understanding of drug development process, Global Clinical development and Medical Writing.

Behavioural Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.
• Ability to multi-task, prioritise and deliver effectively under stringent timelines

About the Department
Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/