Dr. Reddys Laboratories Ltd. – Scientist – Formulation R&D – OSD
To develop the product formula for Oral Solid Dosage Forms, ensure successful pilot & pivotal bio study, process optimization, scale-up and exhibit, respond to deficiencies.
- Design the scheme of experiments. Interpret the results from various analytical instruments like HPLC, UV, GC, IR, etc.
- Visualize the developmental needs of the product.
- Perform experiments for establishing the compatibility between API and excipients.
- Carry out stability at each stage of formulations development.
- Submit samples for conducting pilot and pivotal Bio studies on the PE batch and Exhibit batches respectively in consultation with Biopharmaceutics Team.
- Understand the safety and environmental aspect.
- Solve the problems and queries related to the development of the formulation and discuss them with the Tech Lead.
- Understand/familiarize with the problems faced during Scale-up.
- Understand the scalability of the chosen process.
- Analyze the formulation strategy, efficiency, working relations and cross-functional issues in R&D.
- Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs.
- Keep the work area clean and the laboratory under controlled temperature.
- Maintain the documents well.
Key Personal Attributes:
- Excellent communication & Coordination skills and ability to work with a diverse cross-functional teams.
- High energy & ability to work in ambiguity
- Excellent interpersonal skills; high level of proficiency in networking internally and externally
- Good data analytical skills with creative thinking ability
- Formulation Development-Displays understanding of physical & chemical properties of materials used in formulations and applications to own area through relevant pre-formulation studies.
- Process Engineering-Demonstrates understanding of engineering principles & process controls related to equipment and processes across scales to transfer or receive processes/ products
- Integrated Drug Development-Demonstrates awareness of Dr Reddy’s business, products and research approach as well as competitors drugs/ products to aid product selection process/ support functional delivery
- Regulatory & Compliance-Shows awareness of GXP guidelines, SOPs and internal systems related to own tasks & applies the same in daily operations effectively
- IP Laws & Patents-Shows awareness of IP processes with relation to submission and approval
Internal: FRD, ARD, PEF, PMO, RA, IP, Bio CoE, SCM, FTO, DQA
External: Development partners (CMO/CRO)
Experience & Education: M Pharm with 1-4 years of experience. Should have gained experience in end-to-end product development / process development of Oral Solid dosage forms and delivered 2-3 products overall.