Jr. Scientist Api R&d

**Division**:

- Integrated Product Development

**Department**:

- R&D API

**Sub Department 1**:

- API R&D

**Job Purpose**:
Assist, co-ordinate and get training to develop and execute the process for APIs on time implementation within budget.

**Key Accountabilities (1/6)**:
**Get trained to develop API process in lab by literature survey, API intermediate characterization to ensure the quality and on time implementation**
- Carry out literature survey and discuss with GLs and team members for route selection for assigned project
- Support in Preparing and executing development strategy for the assigned project
- Maintain record book of experiments carried out in lab, results received from the ADL
- Discuss and get trained to 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)**:
**Support team members in preparing development report and MPG on the basis of development work (carried out in lab) in order to successfully transfer the technology in plant**
- Get trained and support in preparing tech Transfer documents like MPG, pre requisite, solubility chart, development report in coordination with ROC based on process developed in lab
- Get trained for pre-requistes for Co-ordinating with manufacturing units for carrying out pilot, pre-validation and validation batches under the supervision of group members and 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 under superivision of group leader.**
- Perform QBD studies by conducting QBD experiments in coordination with QBD team under supervision of Group leader and group members.
- 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)**:
**Key Accountabilities (6/6)**:
**Major Challenges**:
**Key Interactions (1/2)**:
**Internal**
- **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)**:
**Dimensions (1/2)**:

- Process development for 2 or more projects (last year)

**Dimensions (2/2)**:
**Key Decisions (1/2)**:
**Decisions**

Use of Specific reagents, solvents, reaction condition

**Key Decisions (2/2)**:
**Recommendations**

Route selection for development (to GL)

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

**Education Qualification**:
M. Sc. Organic Chemistry

**Relevant Work Experience**:
0-1 yrs in process R&D