Executive - FRD Non-Orals

Roles & Responsibilities:
• Conduct formulation R&D and product development for injectable products in novel drug delivery systems, lyophilized products, and solution products
• Perform literature searches relevant to project requirements and interpret regulatory guidance
• Procure raw materials (API/excipients), packaging materials, and reference products in coordination with packaging and purchase departments
• Prepare requests and applications for testing/analysis licenses for new or reference products
• Design and conduct pre-formulation and formulation experiments using QbD approach, documenting drug product manufacturing experiments in Lab Notebooks
• Prepare TR/IOM for API/excipients/product sample analysis
• Draft product development and stability study protocols and reports; prepare SOPs for laboratory equipment and maintain critical records for regulatory audits
• Compile documentation for technology transfer, including Sheet II, Master Formula, Risk Assessment based on CPP & CQA, FMEA, and SDS
• Manage lab operations, instruments, and group activities, coordinating with cross-functional teams to resolve project-related issues
• Support scale-up, exhibit batches, commercial batches, and new assignments at plant sites
• Prepare Product Development Reports (PDR), Risk Assessment Reports, and compile project issues
• Ensure compliance with internal quality systems and regulatory standards while performing all activities

Qualification:
• M.Pharm in Pharmacy or a related discipline

Experience:
• 2–4 years of experience in formulation R&D, preferably with injectable or non-oral products and novel drug delivery systems

Skills:
• Strong knowledge of pre-formulation, formulation development, and QbD principles
• Experience with regulatory documentation, stability studies, and technology transfer
• Excellent analytical, problem-solving, and documentation skills
• Ability to work collaboratively with cross-functional teams and handle lab operations efficiently

About the Organization:
Sun Pharmaceutical Industries Ltd. is a global leader in the pharmaceutical industry, committed to innovation, quality, and patient-centric healthcare solutions. The company fosters a collaborative environment that encourages professional growth, continuous learning, and opportunities to work on cutting-edge formulation projects across multiple drug delivery systems.