Senior Research Scientist

Experience:

Location:

About Macsen Drugs:

Macsen Drugs is a USFDA-registered, WHO-GMP-certified, TGA-GMP-certified, and EUGMP (Written Confirmation) certified manufacturer of active pharmaceutical ingredients or bulk drugs for varied therapeutic applications like antidote, urinary antiseptic, topical antiseptic, ophthalmic diagnostic, anti-dandruff, anti-acne, and several other applications.  

Job Overview:

We are seeking a skilled and motivated Analytical Research & Development (ARD) Scientist to join our team. The role involves developing and validating analytical methods (HPLC, GC, LC-MS), supporting Synthesis R&D with in-process sample analysis, performing impurity profiling, and ensuring instruments are maintained in top working condition. The ideal candidate should have strong technical expertise in analytical techniques, hands-on experience in method development, and a good understanding of regulatory guidelines.

Key Responsibilities:

Analytical Method Development (AMD):

o Develop and validate HPLC methods for organic molecules, intermediates, and APIs in compliance with AMV (Analytical Method Validation) guidelines.

o Establish HPLC, GC, and LC-MS methods for in-process reaction monitoring samples from Synthesis R&D. 

• Impurity Profiling & Characterization:

o Perform impurity profiling of APIs and intermediates.

o Characterize known and unknown impurities using Mass Spectrometry and related techniques.

• Instrument Maintenance & Calibration:

o Ensure proper upkeep and smooth functioning of analytical instruments (HPLC, GC, LC-MS, etc.).

o Perform regular instrument calibration and troubleshooting.  

• Documentation & Compliance

o Prepare technical documents including SOPs, method validation protocols, and analytical reports.

o Ensure strict adherence to GLP (Good Laboratory Practices) and ICH guidelines. 

• Collaboration & Support:

o Provide analytical support to Synthesis R&D and Quality Control teams.

o Participate in technical reviews, audits, and investigations as required. 

Required Skills & Attributes:

Qualifications & Skills

• M.Sc. / M.Pharm / Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or related field. 

•3–6 years of relevant experience in Analytical R&D within the pharma/chemical industries.

• Strong expertise in HPLC, GC, LC-MS, and other modern analytical techniques.

• Knowledge of impurity profiling, AMV, and regulatory guidelines (ICH/USFDA preferred).

• Excellent problem-solving, documentation, and communication skills.

Why Join Us?

● Opportunity to work with a dynamic and supportive team.

● Exposure to diverse technical challenges and growth opportunities.

● Competitive salary package and professional growth prospects. 

To Apply: Send your updated resume to hrd@macsenlab.com.