Dr Reddy’s Formulation Development Scientist Job – Pharma Apply Online
Scientist Differentiated Formulation Development
Location: 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 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 the global market.
- Ensure successful development of robust stable formula and process for the 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.
- 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 strategy for drug products by preparing effective and comprehensive responses to regulatory queries related to formulation development.
- Facilitate laboratory and equipment maintenance and implementation of company safety standards by preparing and reviewing Standard Operating Procedure (SOP) 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 +7 years or PhD +2 years of experience 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 requirements like Food Drug Approval (FDA) guidelines, Current Good Manufacturing process (cGMP), Current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs).
- Complete understanding of 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 relationships.
- Ability to work collaboratively with own team and cross-functional teams.
- Committed to Learning & Coaching the team.
Link to original notification to apply: APPLY ONLINE HERE
Keywords: Scientist Job, Formulation Development, Pharmaceuticals, Hyderabad, Telangana, India. Dr Reddy’s Formulation Development Scientist Job – Pharma Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
