
Job Title: Pharmaceutical Development Specialist
2 weeks ago
As a highly skilled Research Professional, you will be responsible for leading the development of stable and bioequivalent solid oral dosage forms for global markets. Your key responsibilities will include technology transfer of developed products to plant level, including TTD-related works.
You will work closely with our team to collect and compile data and submit to regulatory agencies. Additionally, you will address DCGI/regulatory agency queries as required, and extend support to plant for commercial trouble shooting.
To succeed in this role, you will need a Ph.D. degree and have strong skills in formulation development, pre-formulation studies, bioequivalence study design & evaluation, technology transfer, scale-up and commercialization, analytical data interpretation, process optimization & troubleshooting, stability studies (ICH Guidelines), equipment handling, and quality by design (QbD). Experience with hands-on formulation and development is also highly desirable.
Key Responsibilities:
- Develop stable and bioequivalent solid oral dosage forms for global markets
- Technology transfer of developed products to plant level, including TTD-related works
- Collect and compile data and submit to regulatory agencies
- Address DCGI/regulatory agency queries as required
- Extend support to plant for commercial trouble shooting
Required Qualifications:
- Ph.D. degree
- Strong skills in formulation development, pre-formulation studies, bioequivalence study design & evaluation, technology transfer, scale-up and commercialization, analytical data interpretation, process optimization & troubleshooting, stability studies (ICH Guidelines), equipment handling, and quality by design (QbD)
- Hands-on experience with formulation and development
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