Sr. Research scientist – AD/Extended Release/ NDDS

Felix Pharmaceuticals Pvt. Ltd.; Varanasi; On-site; INR 1,800,000 - 3,500,000; Full time

Job summary

Felix Pharmaceuticals Pvt. Ltd. is seeking a Sr.

Research Scientist – AD/Research Scientist for Extended Release/NDDS in India. The role focuses on analytical method development, validation, transfer and troubleshooting for APIs and dosage forms, with emphasis on extended-release and sterile injectable products. The candidate will ensure adherence to cGMP/GLP and regulatory guidelines, review data for regulatory submissions, and collaborate with R&D, QA, Regulatory Affairs and Manufacturing to

Qualifications

• M.Sc. in Chemistry or related discipline.
• 10–12 years of relevant analytical experience.
• Strong hands-on experience with analytical techniques and regulatory submissions.

Responsibilities

• Execute analytical method development, validation, verification, transfer and troubleshooting for API and pharmaceutical products.
• Provide analytical support for solid oral dosage forms (tablets, capsules) and injectable formulations, with expertise in extended-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 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 and drive continuous improvement initiatives.

Skills

HPLC/UPLC

GC/GCMS

Dissolution

UV-Vis

FTIR

Method development

Data integrity

Regulatory filings

Education

M.Sc. in Chemistry / Analytical Chemistry / Pharmaceutical Chemistry

Job description

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
• Strong "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