R&D Specialist (Formulation Development) - (Controlled Medicines & Injectables) | Saudi Arabia
On-siteMumbai, Maharashtra, India
Job Summary
Develop and optimize formulations for controlled and injectable pharmaceutical products, conducting laboratory-scale trials to evaluate critical quality attributes for parenteral dosage forms. Select and qualify excipients and raw materials while designing, executing, and analyzing stability studies in accordance with ICH and SFDA guidelines. Support reformulation projects, pilot and commercial-scale batch execution, and technology transfer documentation. Investigate and document formulation-related OOS, OOT, and deviation reports, and prepare CTD/eCTD submission modules. Ensure compliance with FDA, EMA, and ICH standards throughout development and provide technical support during process validation and regulatory inspections.
Required Qualifications
- Bachelor's or Master's Degree in Pharmacy or Pharmaceutical Sciences
- Minimum 5 years of hands-on experience in pharmaceutical formulation development of Controlled Medicines and/or Injectables (Parenteral products)
- Hands-on experience in sterile dosage forms, formulation optimization, and stability testing
- Strong understanding of global regulatory standards (FDA, EMA, ICH, SFDA)
- Excellent analytical, documentation, and communication skills
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