Dr Reddy’s Formulation Specialist Role For Pharma – Apply Online
Formulation Specialist – DF
Khairatabad, 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 Specialist in the Formulation Development team to develop the product formulation, ensure successful pilot & pivotal bio study, scale-up and exhibit, respond to deficiencies with proper justification. Ensure successful development of a robust stable formula and process for the given product from bench scale to commercial level.
Roles & Responsibilities
- 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 response 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 pharma
- Minimum work experience: 7 years of experience in Differentiated Formulation Development
Skills & attributes
Technical Skills
- Experience in end-to-end differentiated product development and troubleshooting
- Developed Platform Technology Based Differentiated Solid oral dosage forms and delivered 3-4 products overall for global markets
- Preferred area of expertise is Extended and Sustained Release Oral solid dosage forms. Global product development experience is preferred. Experience on oral peptide drug delivery is preferred
- 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 such as Intellectual Property (IP) laws and patents; developmental quality aspects
Behavioural 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
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