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 solid 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:
Solid 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