Hiring API ADL Analyst at Cipla - M.Pharm, MSc Apply

Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.

Post : API ADL Analyst

Job Purpose
Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements

Job Description
Key Accountabilities (1/6)
Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission
• Conduct extensive literature search
• Analyse raw materials, intermediates, final API, forced degradation samples, stability samples, GTI’s on different analytical instruments under GLP environment
• Conduct Fate and Purge studies/carryover studies
• Perform method validation
• Prepare specification based on carryover studies
• Perform method transfer to manufacturing units for routine QC analysis

Key Accountabilities (2/6)
Investigate plant queries like OOS, OOT for quality control of drug substance and products in order to provide corrective actions and check samples for impurities
• Review the entire process to identify the source of impurities
• Perform degradation study to identify impurities
• Analyse packing material in case of leachable and extractable

Key Accountabilities (3/6)
Characterise final API and impurities to prepare the test or working standards for routine laboratory purpose
• Perform chemical and physicochemical analysis to arrive at the purity, potency and structural identity of the molecule
• Store impurities as per chemical properties

Key Accountabilities (4/6)
Conduct the incubation and perform complete analysis of stability samples to conclude the storage, shelf life and packing conditions of the final API
• Incubate samples at various conditions
• Select packing material
• Perform analysis of stability samples
• Compile trend and identify degrading impurity
• Evaluate shelf life of the drug substance for expiry conclusion

Key Accountabilities (5/6)
Keep track of the latest innovation and applications which can be used with the existing techniques to investigate / resolve critical issues
• Attend various webinars, conferences
• Evaluate various demo data’s generated by instrument manufacturers at their demo labs
• Compare various parameters like shorter run time, solvent consumption, cost factor and environment safety

Key Accountabilities (6/6)
Major Challenges
• Changes in the Regulatory guidelines: Keeping abreast with latest regulatory guidelines and interaction with RA department
• Conflict regarding the priorities of samples: Interaction with cross-functional team along with the managers to prioritise the samples
• Delay in cross-functional activities: Interaction with immediate supervisor for clarity of responsibility
Difference in instrument compatibility for analysis: Escalated to supervisors

Candidate Profile
• M.Sc. Chemistry/ M.Pharma / PGD
• Minimum 1- 5 years of experience in pharmaceutical industry with analytical experience Good presentation and communication skills are preferable

Additional Information
Experience : 1-5 years
Qualification : M.Pharm, MSc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : ADL
End Date : 30th September 2025