Lupin Hiring Analytical R&D for injectables

Lupin limited; Mumbai, Pune District; On-site; INR 900,000 - 1,500,000; Full time

Benefits offered by this job

Health insurance

Training programs

Career advancement opportunities

Performance incentives

Job summary

Lupin Limited – Research Park in Pune seeks a Research Associate / Associate Scientist in Analytical R&D (Injectables). You will develop and validate analytical methods for liquid and lyophilized injectables, drive method transfers, and contribute to regulatory submissions.

The role requires 3–9 years in Analytical R&D, proficiency with HPLC/GC/UV, and hands-on experience with GLP/GMP, ICH Q2(R1), and data integrity practices. Pune-based, full-time on-site position with growth opportunities.

Qualifications

• M.Pharm or M.Sc with analytical chemistry focus.
• 3–9 years in Analytical R&D for injectables.
• Experience with method development and validation.

Responsibilities

• Develop, validate analytical methods for liquid and lyophilized injectables.
• Conduct stability studies and impurity profiling.
• Transfer methods to QC/Manufacturing teams.
• Prepare and review analytical protocols, reports, and regulatory documents (CTD/ANDA).
• Support troubleshooting of analytical issues during development and validation.
• Ensure GLP, GMP and ICH Q2(R1) compliance.
• Maintain data integrity per ALCOA+ and 21 CFR Part 11.

Skills

Analytical R&D

HPLC

GC

UV

Empower

Chromeleon

Regulatory knowledge

cGMP

Education

M.Pharm / M.Sc (Analytical Chemistry)

Tools

CTD/AND A docs

Job description

M.Pharm/M.Sc Analytical R&D Openings – Lupin Research Park Pune

Lupin hiring M.Pharm/M.Sc professionals with 3–9 yrs experience in Analytical R&D for injectables at Pune.

Lupin Limited, one of India’s top global pharmaceutical companies, is inviting applications for Research Associate / Associate Scientist – Analytical R&D (Injectables) positions at its Research Park in Pune. This role is ideal for professionals passionate about analytical method development, validation, and innovation in injectable formulations.

Join Lupin’s advanced research division and contribute to the development of complex injectable products that impact patients worldwide.

Company Overview

Lupin Limited is a leading multinational pharmaceutical company headquartered in Mumbai, India. With over five decades of excellence, Lupin operates across therapeutic areas such as cardiovascular, diabetology, oncology, and respiratory diseases, and is known for its strong global presence in generics, biosimilars, and specialty formulations.

The Lupin Research Park (LRP), Pune, serves as a global hub for drug discovery and development. It focuses on advanced formulation research, analytical sciences, process optimization, and regulatory compliance to deliver high-quality pharmaceutical products meeting stringent international standards.

Working at Lupin means joining a culture that fosters innovation, scientific rigor, and a shared mission to serve life through better medicines.

Job Role & Responsibilities

As a Research Associate / Associate Scientist in Analytical R&D (Injectables), you will play a critical role in developing and validating analytical methods to support the formulation and process development of liquid and lyophilized injectable products.

Key Responsibilities

• Develop, optimize, and validate analytical methods using HPLC, GC, UV, IR, and other advanced analytical instruments.
• Perform stability studies, impurity profiling, and method transfer to manufacturing and quality control teams.
• Prepare and review analytical protocols, reports, and regulatory documents (CTD, ANDA, DMF sections).
• Support troubleshooting of analytical issues encountered during development and validation.
• Collaborate closely with formulation scientists and process engineers to align analytical results with formulation performance.
• Ensure compliance with GLP, GMP, and ICH Q2(R1) guidelines throughout all analytical activities.
• Maintain accurate laboratory records and ensure data integrity following 21 CFR Part 11 and ALCOA+ principles.

Eligibility / Qualifications

Educational Qualification:

• M.Pharm (Pharmaceutical Analysis / Pharmaceutics) or M.Sc (Analytical Chemistry / Organic Chemistry / Chemistry).

Experience:

• 3 to 9 years of relevant experience in Analytical R&D for injectables (liquid or lyophilized dosage forms).

Preferred Skills:

• Strong hands-on experience with HPLC, GC, and UV spectroscopy.
• Proficiency in analytical software such as Empower or Chromeleon.
• Knowledge of regulatory guidelines (USFDA, EMA, MHRA) for method validation and documentation.
• Good understanding of ICH Q1–Q14 guidelines, cGMP practices, and analytical data trending.
• Strong written and verbal communication for report writing and cross-functional collaboration.

Relevant Courses (comma-separated):
M.Pharm Pharmaceutical Analysis, M.Pharm Pharmaceutics, M.Sc Analytical Chemistry, M.Sc Organic Chemistry, Certification in HPLC Method Development, Advanced GMP & GLP Compliance, Data Integrity in Pharma.

Note: Candidates with experience in injectable formulation analytics will be preferred.

Location & Salary

Location: Lupin Research Park, Pune, Maharashtra
Employment Type: Full-time, On-site
Salary: Competitive and commensurate with experience
Benefits: Health insurance, performance incentives, training programs, and career advancement opportunities.

Lupin offers a stimulating work environment with exposure to global analytical standards and continuous learning through collaboration with industry experts.

Why Join Lupin R&D?

• Work in one of India’s most advanced pharmaceutical research environments.
• Gain hands‑on experience with high‑end analytical instruments for complex injectables.
• Be part of global regulatory submission projects (USFDA, EMA, WHO).
• Opportunities for skill enhancement and cross‑functional learning.
• Contribute to innovative drug development projects that serve patients across the world.

FAQs

Q1. What is the experience requirement for this role?
A1. Candidates should have 3–9 years of experience in Analytical R&D, specifically in injectables (liquid or lyophilized dosage forms).

Q2. What techniques should candidates be proficient in?
A2. HPLC, GC, UV, and impurity profiling for analytical method development and validation.

Q3. Is regulatory documentation experience required?
A3. Yes, knowledge of CTD/ANDA submission and ICH guidelines is essential.

Q4. Are M.Sc candidates eligible to apply?
A4. Yes, M.Sc graduates in Analytical or Organic Chemistry with relevant experience can apply.

Q5. Where is this position based?
A5. The role is based at Lupin Research Park, Pune, Maharashtra.

Company: Lupin Limited – Research Park

Vacancies: Research Associate / Associate Scientist

Required Education: M.Pharm / M.Sc (Analytical Chemistry or related field)

Experience: 3–9 Years (Injectable Analytical R&D)

Location: Pune, Maharashtra