Role & responsibilities

KEY JOB RESPONSIBILITIES

1. Perform formulation development activities (tablet/capsules) on innovative approach for new chemical entities to achieve product development within stipulated timeline while ensuring good lab and documentation practices.
2. Experience of transferring the developed product to GMP site and monitor clinical batch manufacturing.
3. Execution of preclinical and formulation development work packages.
4. Perform the solubility, stability, excipient compatibilities studies etc., of new chemical entities and apply this knowledge to develop robust product.
5. Operational execution of phase appropriate formulation development studies for exploratory projects i.e. API/Blend in Capsule, API/Blend in bottle, Tablets, Capsules etc. (Early phase formulation development).
6. Prepare and review the Technology Transfer Document (TTD), Batch manufacturing Record (BMR), Product Development Report (PDR), Risk assessment and other regulatory documents for product development.
7. Support and coordinate application of various regulatory licenses required for R&D;, clinical and import/export of drug substance and product.
8.



Ability to collate and scientifically present the data & observations and provide scientific inputs in discussions with internal or external customer (clients).
9. Prepare reports/presentations/SOPs/guidelines/URS/protocols/reports, follow good documentation practices and record observations in Electronic Lab Notebook (ELN) or manual Lab Notebook (LNB).
10. Collaborate and work across functions and engage in cross departmental activities to ensure timely completion of project as per requirement.
11. Support in developing, maintaining and upgrading the existing lab facility and support facility team to maintain and run the lab efficiently.

Key Competencies (Technical, Functional & Behavioural) Technical & Functional

- Sound experience of fundamentals of pre-formulation, preclinical formulation and clinical formulation development.
- Excellent problem-solving and experimental skills.
- Robust written and verbal communication skills.

QUALIFICATION AND EDUCATION:

- M.S. Pharm or M. Pharm. In Pharmaceutics or pharmaceutical technology formulations with 5 to 7 years of relevant industrial experience.

📌 Pre Formulations -Research Associate-Shameerpet (Hyderabad)
🏢 Sai Life Sciences
📍 Hyderabad