Formulation Scientist

Role:  Formulation Scientist FR&D Global Dossier Leverage Team

Purpose:

• To support ever expanding Business opportunities in various Emerging Markets by means of Leveraging the Lead geography dossiers
• To strengthen the technical support required in identifying and fulfilling the Gaps for dossier extension to key Emerging geographies

Roles & Responsibilities

• To perform technical evaluation of identified projects with respect to emerging geography filing requirements along with regulatory team    
• Support in bridging gaps identified by regulatory team
• Visualize the developmental needs of the product as per requirements of Emerging geography and ensure the same is communicated to the product development team
• Evaluate and support responding regulatory deficiencies
• Coordinate with respective cross functional teams to support timely leverage of dossiers to above markets
• Drive the requirements through effective coordination with various cross functional teams.
• Tracking the progress of leverage projects along with Regulatory and business teams
• Drafting submitting applications with all necessary information to RA for related License applications for Testing/BE study conduct etc.
• Responsible for technical evaluation of batch for bioequivalence studies against the country specific reference products
• Shall be responsible for execution of lab scale batches (on need basis) required to fulfil filling requirements
• Responsible for planning Raw material requirement and initiation of related requests to SCM for batch execution purpose/lab scale batches/Fulfilling Method validation requirements where necessary
• Identification and planning of Finished product batches as per the specific country requirement
• Providing the inputs for RLD Qty. API/RM/PM Qty Analytical prerequisites batch cost (if required) and developmental cost (in case of change in RM source)
• Monitoring and tracking of Global development projects and ensuring  Emerging Market requirements are inbuilt during  product development
• Preparing scientific justification wherever required before apex clearance to take the respective regulatory body concurrence before filing.
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• Coordination with crossfunctional teams:
• Drafting submitting applications with all necessary information to RA for related Lics 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
• Should have fair understanding on bio equivalence studies
• Should exhibit problem solving skills

• Documentation:

• Should be efficient with Microsoft Word Excel and Power point
• Maintaining the documents well
• Compilation of formulation and analytical data for technical and commercial decisions in the projects

• Key Personal Attributes:

• Effective coordination and communication skills
• Planning and Time Management
• Selfmotivated  and proactive

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Qualifications :

Educational qualification: Masters (M.Pharm)

Minimum work experience: 58 years of experience in Formulation development 

Skills & attributes:
Technical Skills

• Experience in endtoend product development and troubleshooting.
• Developed Oral Solid dosage forms and delivered 34 products overall for regulated/semiregulated markets.
• 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).

Behavioral Skills

• Excellent communication and interpersonal skills.
• Business Acumen & Decision Making
• Strong analytical and problemsolving abilities.
• Performance oriented and good at building leveraging relationship.
• Ability to work collaboratively with own team and crossfunctional teams.
• Committed to Learning & Coaching the team. 

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused 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 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 !/ 

Remote Work :

No

Employment Type :

Fulltime