Formulation Research Scientist

Job Summary

We are seeking a highly motivated Formulation Development professional with 37 years of experience to support formulation development activities for oral solid and liquid dosage forms. The role involves working in a CRO/CDMO environment, supporting multiple client programs including big pharma and innovative companies, with a strong focus on scientific rigor, minimal-intervention clinical batch manufacturing, and effective cross-functional communication.

Key Responsibilities

1. Design, develop, and optimize oral solid dosage forms (IR, MR, modified release) and oral liquid formulations for preclinical and clinical studies.

2. Execute formulation development, scale-up, and clinical batch manufacturing with minimal intervention and high first-time-right approach.

3. Provide strong scientific rationale for formulation selection, excipient choice, and process parameters.

4. Support technology transfer from R&D to mfg facility or client site.

5. Plan and execute DoE, risk assessments, and troubleshooting during formulation and process development.

6. Prepare and review development reports, protocols, batch records, and regulatory-supporting documentation.

7. To prepare presentation slides for client meeting and internal discussions.

8. Collaborate closely with analytical, manufacturing, quality, and project management teams.

9. Interact with clients to present development strategies, results, and justifications

10. Ensure compliance with cGMP, data integrity, and internal quality systems.

11. To prepare SOP’s, new system implementations, perform equipment qualification activities on need basis.

Required Technical Skills & Expertise

1. Strong understanding and hands-on experience in oral solid dosage form development (granulation, compression, coating).

2. Experience in oral liquid formulation development (solutions, suspensions).

3. Hands-on exposure to clinical batch manufacturing with minimal manual intervention.

4. Solid knowledge of preformulation, excipient functionality, dissolution, and stability principles.

5. Strong scientific thinking and problem-solving capabilities.

6. Experience in handling Minitab or Design expert software.