API ADL Analyst

Division

Department

Sub Department 1

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                                                

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

Key Interactions (1/2)

• API R&D/ F R & D for planning, product information and result discussion (daily)
• RA for regulatory discussion for Deficiency, DMF filing (as per need basis)
• IP or patenting any product or getting information of any known patent (as per need basis)
• Units for sample requirement, Method transfer, Method validations, investigations (weekly)
• Purchase & Imports for impurities/chemicals, instrument and Equipment (as per need basis)

HR for Personal discussion and organisation rules and regulation, company policy discussion (as per need basis)

Key Interactions (2/2)

• Outsource Labs- for external analysis (weekly)
• Vendors-Instruments/Equipment for service and support (as per need basis)
• Application specialists for application support to resolve any challenging queries (as per need basis)

Dimensions (1/2)

• Minimal error for lab compliance and maximise output
• Maximise instrument utility by working in shifts
• Online delivery of analytical data to R&D
• Ensuring 100% compliance with the regulatory
• Meet the turnaround times for projects
• Publish two papers in a year

Dimensions (2/2)

Number of trials on various techniques during development stages

Key Decisions (1/2)

Result discussion for online monitoring of samples - with R&D

Change in method of analysis with supporting

analytical data  - to the respective Group Leader

Key Decisions (2/2)

Education Qualification

M.Sc. Chemistry /M Pharma / PGD

Relevant Work Experience

• Minimum 1- 5 years of experience in pharmaceutical industry with analytical experience

Good presentation and communication skills are preferable