Are you passionate about analytical chemistry and regulatory science?
Amneal Pharmaceuticals Pvt. Ltd is inviting applications for the position of Executive – Analytical R&D (Extractable & Leachable, OSD).
This role is ideal for analytical experts who want to lead method development, validation, and E&L studies supporting high-quality pharmaceutical formulations.
Key Responsibilities
- Conduct extractable and leachable (E&L) studies on packaging components, medical devices, and drug products.
- Perform sample preparation, extraction, and analysis using HPLC, GC-MS, LC-MS, ICP-MS, ICP-OES.
- Develop and validate analytical methods in compliance with USP <1663>, <1664> and related guidelines.
- Interpret analytical data and identify unknown compounds.
- Prepare technical reports, protocols, and regulatory documentation.
- Maintain and calibrate laboratory instruments per GLP/GMP standards.
- Collaborate with cross-functional teams—Formulation, QA, and Regulatory Affairs.
- Ensure compliance with laboratory safety protocols and data integrity norms.
Qualifications & Experience
- M.Sc. / M.Pharm / Ph.D. in Analytical Chemistry or related field.
- 3–5 years of experience in Extractable & Leachable testing.
- Proficiency in HPLC, GC-MS, LC-MS, ICP-MS, ICP-OES.
- Solid understanding of E&L regulatory requirements.
- Strong analytical thinking, documentation, and communication skills.
Preferred Skills:
Experience with polymer chemistry, material characterization, and toxicological risk assessment is an advantage.
Why Join Amneal Pharmaceuticals?
- Opportunity to work with world-class analytical teams.
- Exposure to global regulatory projects.
- Inclusive workplace with diversity and equal opportunity.
- Competitive salary: ₹6–9 LPA based on experience.
- Learning-driven environment fostering innovation.
Location
📍 Pharmez SEZ, Plot No. 15–17, Ahmedabad, Gujarat – 382110
How to Apply
Interested candidates can apply now via Pharmabharat.com or visit the official Amneal careers portal.
Application Deadline: October 26, 2025
FAQs
Q1: What is the primary focus of the Analytical R&D Executive (E&L) role?
A: The focus is on method development, validation, and analysis for extractable and leachable studies in oral solid dosage forms.
Q2: What instruments are primarily used for E&L testing?
A: Major instruments include HPLC, GC-MS, LC-MS, ICP-MS, and ICP-OES, aligned with global regulatory standards.
