Designation: Sr. Research scientist – AD/Research Scientist
- Extended Release/ NDDS Qualification: M.
Sc. (Chemistry / Analytical Chemistry / Pharmaceutical Chemistry or relevant discipline)

Experience:
10–12 Years

Key Responsibilities
• Execute analytical method development, validation, verification, transfer, and troubleshooting activities for API & pharmaceutical products.
• Provide analytical support for solid oral dosage forms (tablets, capsules) and injectable formulations, with strong expertise in extended-release, sustained-release, and delayed-release products.
• Review and approve analytical protocols, reports, specifications, stability data, and regulatory submissions.
• Ensure compliance with cGMP, GLP, ICH, USP, EP, IP, and other applicable regulatory requirements.
• Support product development, scale-up, exhibit batch analysis, process validation, and commercial manufacturing activities.
• Handle deviations, CAPA, change controls, and laboratory investigations.
• Manage stability studies and trending of analytical data.
• Coordinate with cross-functional teams including R&D;, QA, Regulatory Affairs, Production,



and Technology Transfer.
• Internal audit preparation, encourage team members while driving continuous improvement initiatives for departments, and organization.
• Required Expertise:
• Strong hands-on experience in HPLC, UPLC, GC/GCHS, Dissolution, UV-Vis, FTIR, and other analytical techniques.
• Proven expertise in analytical challenges associated with modified-release formulations (Extended Release/Sustained Release/Delayed Release) and sterile injectable products.
• Sound knowledge of ICH guidelines, pharmacopeial requirements, method lifecycle management, and data integrity principles.
• Experience in regulatory filing support for international markets e.g. US and Europe Key Competencies:
• Robust "Can-Do" and "To-Do" attitude
• High level of ownership and accountability in delivering results within timelines
• Analytical problem-solving
• Compliance in day-to-day activities
• Effective and continuous communication within the department and other stakeholders

📌 Sr. Research scientist – AD/Extended Release/ NDDS (Karamba)
🏢 Felix Pharmaceuticals
📍 Karamba