We are seeking a highly motivated Formulation & Development (F&D;) Scientist/Executive for Oral Solid Dosage (OSD) products. The candidate will be responsible for formulation development, process optimization, technology transfer, and regulatory documentation for generic pharmaceutical products.
Key Responsibilities
- Develop and optimize formulations for tablets, capsules, and multiparticulate dosage forms.
- Conduct pre-formulation, compatibility, and prototype studies.
- Design and execute laboratory-scale and exhibit/registration batches.
- Prepare development reports, protocols, and technical documents.
- Support technology transfer activities to manufacturing sites.
- Perform troubleshooting during scale-up, validation, and commercialization.
- Review analytical data and ensure compliance with regulatory requirements.
- Coordinate with Analytical Development, Regulatory Affairs, QA, and Production teams.
Required Qualifications
- Education: M.Pharm (Pharmaceutics) with relevant experience.
- Experience: 28 years in Formulation & Development of OSD products.
- Hands-on experience in tablet and capsule formulation development.
- Knowledge of QbD, DOE, ICH guidelines, and regulatory requirements for ANDA/ROW markets.
- Experience with granulation, compression, coating, and scale-up activities.
- Good documentation and communication skills.
Desired Skills
- Problem-solving and scientific reasoning.
- Exposure to technology transfer and process validation.
- Robust understanding of excipients and formulation strategies.
- Ability to work in a cross-functional team environment.