Scientist – Analytical R&D (Formulation OSD) – Regulated Market
About the Job
Job Title: Scientist – Analytical R&D (Formulation OSD) – Regulated Market
Designation: Assistant Manager (AM Level)
Qualification: M.Pharm / M.Sc. (Chemistry)
Experience: 8–11 Years
Location: South Side
.
Key Responsibilities:
- Perform method development and validation for assay, related substances, and dissolution tests.
- Execute stability sample analysis and ensure compliance with ICH guidelines.
- Prepare and review method development, validation, and transfer protocols/reports.
- Handle change controls, SOPs, specifications, and standard test procedures.
- Operate and calibrate analytical instruments (HPLC, GC, Dissolution apparatus, etc.).
- Support regulatory dossier preparation with relevant analytical documentation.
- Participate in investigations (OOS/OOT) and contribute to continuous improvement.
- Perform risk assessments for elemental impurities, residual solvents, and nitrosamines.
Required Skills & Competencies:
- Strong knowledge of analytical method development and validation.
- Working experience with regulated markets (USFDA, MHRA, EMA).
- Proficiency in instrument operation, troubleshooting, and data integrity practices.
- Good communication and documentation skills.
About the Company
Overview
BIG PHARMA JOBS is India’s leading recruitment platform dedicated exclusively to the Pharmaceutical industry. Since 2010, we have been connecting top talent with leading pharma companies through our specialized recruitment services.
We operate under our parent company, BIG IDEAS HR Consulting Pvt. Ltd., a trusted name in the HR industry. Headquartered in Ahmedabad, we have expanded our footprint with branch offices in Pune, Bangalore, Indore, Noida, and more.
Over the past decade, we have proudly partnered with 1,000+ pharma companies and successfully placed over 25,000 candidates across various domains and levels.
To further strengthen our commitment to the pharma ecosystem, we have recently launched our own job portal – a dedicated platform designed to serve pharmaceutical professionals and companies alike. This portal aims to be a one-stop recruitment solution, simplifying the hiring process and job search experience in the pharma sector.
At BIG PHARMA JOBS, our vision is to create India’s most trusted and comprehensive job portal for the pharmaceutical industry – empowering careers and building organizations, one placement at a time.
Skills
Key Details
- Experience:
- 8 to 12 years
- Job Domain/Function:
- Pharma Formulation
- Job Type:
- Work From Office
- Employment Type:
- Full Time
- Number of position(s):
- 1
- Educational qualifications:
- M.Pharma, MSc(Chem)