Dr Reddy’s Formulation Scientist Role For Pharmaceutics, Apply Online
Formulation Scientist – Differentiated Formulations
Hyderabad, Telangana, India
About the Job
Company Description
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.
Job Summary
We are seeking a dynamic and experienced Scientist in the Differentiated Formulation Development team to:
- Develop differentiated product formulations.
- Ensure successful completion of PoC/pilot & pivotal bio study, scale-up and exhibit.
- Respond to deficiencies with proper justification for global markets.
- Ensure successful development of robust, stable formulas and processes for products from bench scale to commercial level.
Roles & Responsibilities
- Review and analyze 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.
- Evaluate available information and consult with experts to devise contingency strategies, ensuring proactive identification of potential formulation development challenges during the strategy development phase.
- 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.
- Perform and review experiment documentation as per company systems (ELN). Write batch plans, protocols, sampling plans, etc.
- Ensure robust regulatory strategies for drug products by preparing effective and comprehensive responses to regulatory queries related to formulation development.
- Facilitate laboratory and equipment maintenance and implement company safety standards by preparing and reviewing Standard Operating Procedures (SOPs) pertaining to the function.
- Provide guidance to develop formulation capabilities within the team.
Qualifications
Educational Qualification:
- Masters/Ph.D. in Pharmaceutics
Minimum Work Experience:
- M. Pharm +2 years or Ph.D. 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 the 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 and process controls related to equipment and process scale-ups.
- Knowledge of agency requirements such as FDA guidelines, Current Good Manufacturing Practices (cGMP), Current Good Laboratory Practices (cGLP), and Standard Operating Procedures (SOPs).
- Complete understanding of prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation, and regulatory aspects.
- Knowledge of Intellectual Property (IP) laws and patents; developmental quality aspects.
Behavioral Skills
- Excellent communication and interpersonal skills.
- Business acumen and decision-making abilities.
- Strong analytical and problem-solving abilities.
- Performance-oriented and adept at building and leveraging relationships.
- Ability to work collaboratively with own team and cross-functional teams.
- Committed to learning and coaching the team.
Link to Original Notification: APPLY ONLINE HERE
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