Scientist

Division

Department

Sub Department 1

Job Purpose

Develop, optimise and execute the process for APIs to ensure on time implementation within budget

Key Accountabilities (1/6)

Develop API process in lab by literature survey, API intermediate characterization to ensure the quality and on time implementation

• Carry out literature survey and route selection for assigned project
• Prepare and execute development strategy for the assigned project
• Maintain record book of experiments carried out in lab, results received from the ADL
• Optimize process parameters to achieve process robustness for ensuring successful completion of lab trial and lab confirmatory batches with optimised costs
• Support creation of  new IP assets for the company by performing experiments related to innovations like new process and polymorphs
• Maintain and calibrate the instruments in lab as per calibration schedule
• Follow individual safety procedures while working in lab by following GLP
• Follow the green chemistry approach while conducting experiments

Key Accountabilities (2/6)

Prepare development report and MPG on the basis of development work (carried out in lab) in order to successfully transfer the technology in plant

• Prepare tech Transfer documents like MPG, pre requisite, solubility chart, development report in coordination with ROC based on process developed in lab
• Coordinate with manufacturing units for carrying out pilot, pre-validation and validation batches under the supervision of group leader

Key Accountabilities (3/6)

Conduct QbD study, carryover study, impurity (genotoxic) identification / synthesis / characterization to achieve regulatory compliance and minimize the deficiencies in the DMF filling

• Perform QBD studies by conducting QBD experiments  in coordination with QBD team
• Conduct impurity profile and carryover studies, impurity (genotoxic) identification / synthesis / characterization.

Key Accountabilities (4/6)

Support procurement in identifying and finalising the vendors for key raw materials by performing vendor qualification to achieve on time implementation

• Carry out experiments required for vendor qualification on receipt of material
• Compare and derive trend data for shortlisting vendors by comparing materials received

Key Accountabilities (5/6)

Ensure compliance of checklist for stage gate and milestone meetings to complete the project within time

Carry out the listed activities in the stagegate and milestone checklists within time

Key Accountabilities (6/6)

Major Challenges

Delay in getting analytical results from ADL causes delay in the overall development of project

2. Re-conducting experiments in cases of incorrect quality raw material being received from procurement (due to rejections). Bring to the notice of group leader in such cases.

3. Rework as more experiments need to be performed due to changing requirements for product development.

Key Interactions (1/2)

• Manufacturing, SCM and  ADL for receiving samples and delivering results (frequently)
• QA and QC for quality related procedures (frequently)
• IP for inputs regarding literature (need basis)
• ROC for documentation support (frequently)
• Safety for safety information (frequently)
• Engineering for machine maintenance (need basis)

Key Interactions (2/2)

  Vendors and suppliers for raw materials and instruments, equipment (need based)

Dimensions (1/2)

• Process development for 4 projects (last year)
• Execution of process on plant for 1 project (last year)

Dimensions (2/2)

Key Decisions (1/2)

Use of Specific reagents, solvents, reaction condition

Key Decisions (2/2)

Route selection for development (to GL)

Specific vendor for raw materials, instruments and equipment (to SCM)

Education Qualification

Educational qualifications:

M. Sc. Organic Chemistry

Relevant Work Experience

3-5 yrs in process R&D