Formulation Scientist - Differentiated Formulations

Job Summary We are seeking a dynamic and experienced Scientist in Differentiated Formulation Development team to develop the differentiated product formulation, ensure successful completion of PoC/pilot & pivotal bio study, scale-up and exhibit, respond to deficiencies with proper justification for global market. 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 evaluate available information and consult with experts to devise contingency strategies, ensuring proactive identification of potential formulation development challenges during the strategy development phase.
• You will be responsible to strategize and oversee product development, ensuring timely milestone achievements and effective formulation experiments. Coordinate daily analysis plans with the Analytical team, proactively addressing potential challenges and ensuring resource availability. Facilitate pilot and exhibit batch processes, collaborate on process optimization trials, and contribute to PDR and filing preparation for the development of a robust and stable bioequivalent drug product.
• 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.
• You will be responsible to facilitate laboratory and equipment maintenance and implementation of company safety standards by Preparing and reviewing Standard Operating Procedure (SOP) pertaining to the function.
• You will be responsible to provide guidance to develop formulation capabilities within team. 

Educational qualification: Masters/Ph.D. in Pharmaceutics Minimum work experience: M Pharm +2 years or PhD in Differentiated Formulation Development  Skills & attributes: Technical Skills

• Experience in end-to-end product development and troubleshooting in platform technology based differentiated formulation development for global market.
• Developed Oral Solid dosage forms and delivered 3-4 products overall for global 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).
• Complete understanding on prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation and regulatory aspects Intellectual Property (IP) laws and patents; developmental quality aspects.   

Behavioral Skills

• Excellent communication and interpersonal skills.
• Business Acumen & Decision Making
• 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.
• Committed to Learning & Coaching the team. 

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/#!/