Formulation 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 centres, manufacturing facilities or a commercial presence in 66 countries. 

For nearly 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 Scientist in Formulation Development team to leverage and develop the product formulation, ensure successful pilot & pivotal bio study, scale-up and exhibit, respond to deficiencies with proper justification. Ensure successful development of robust stable formula and process for given product from bench scale to commercial level.

Roles & Responsibilities

• You will be responsible to Review and analyse data, collaborating with the Strategy design team to prioritize product criticality and plan preformulation studies. Coordinate with the preformulation team to strategize reverse engineering studies for comprehensive characterization.
• You will be responsible to Involve in product selection for respective geography which includes performing literature search including patent analysis,Technical due diligence with gaps identified and proposed mitigation plan, along with cost analysis ,Identify/Anticipate risks associated with filing strategy and proposing risk mitigation plans
• Identify the Project prerequisites and fill the identified gaps by working towards activities such as ensuring Import permissions availability, Providing License information to RA,Test/RLD samples procurement, additional data generation if any, Documentation including PDR rewriting, preparing scientific justifications, Risk assessment documents, Stability protocols etc
• You will be responsible to perform and review experiment documentation as per company systems (ELN). Write Batch plans, protocols, sampling plans etc.
• You will be responsible to ensure robust regulatory strategy for drug products by preparing effective and comprehensive response to regulatory queries related to formulation development.
• Execute R&D experiments where necessary, Data analysis and Interpretation, Design of specification, Involving and Tracking additional EB batch executions for EM countries, address issues during batch executions etc 
• Post filing support like Technical evaluation during BE lot selection, Submission of samples for BE studies execution, PE/PQC samples availability for respective geographies, Deficiency response to CMC queries 
• Visualize the developmental needs of the product as per requirements of Emerging geography and ensure the same is communicated to the product development team on Global development products
• Self-drive the projects, Take overall responsibility of the projects with effective communication and CFT coordination

Educational qualification: Masters in pharma

Minimum work experience: 7-8 years of experience in Formulation development 

Skills & attributes:
Technical Skills

• Drafting, submitting applications with all necessary information to RA for related Licenses and material procurement as required with SCM for smooth functioning in product leverage.
• Hands on experience in Formulation/Process /Analytical research and development for oral solids
• Should have good data analytical skills and technical report writing
• Knowledge on general regulatory requirement , selected person will be provided with know-how on regulatory requirements for above markets
• Should have fair understanding on bio equivalence studies
• Good theoretical and practical understanding of different stages of formulation research and development 
• Demonstrates theoretical knowledge of commonly used analytical evaluation and characterization tools.
• Basic understanding of engineering principles & process controls related to equipment and process scale ups.
• Knowledge of agency requirement like Food Drug Approval (FDA) guidelines; Current Good Manufacturing process (cGMP), Current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs
• Documentation:
• Should be efficient with Microsoft Word, Excel and Power point
• Maintaining the documents well
• Behavioral Skills
• Excellent communication and interpersonal skills.
• Planning and Time Management
• Strong analytical and problem-solving abilities.
• Performance oriented and good at building, leveraging relationship.
• Ability to work collaboratively with own team and cross-functional teams.

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/#!/