Pupose:
Delivering value to the business by delivering product, post detailed analytical studies through effective methods and activities-

• Deliver analytical results to in defined timeframe to meet product delivery goals for I&D
• To develop analytical methods for drug substance, drug product and packaging material.
• To perform analysis of developmental batches, validation and stability batches
• To perform activities related to method transfer at site

To carry out good documentation practices for all the analytical activities.
Core Job Responsibilities
Development

• Literature search related to the drug substance, create analytical profiles.
• Develop suitable analytical method for drug substance or drug product if not in Pharmacopoeia
• To carry out characterization of the API and conduct pre-formulation studies as planned by the formulator
• To conduct analysis of development samples as received from formulator and provide them with analytical report in the defined timeline.

Instrumentation

• To conduct calibration of allotted equipment with proper documentation and maintain the equipment in good condition. To follow the SOP of usage and document in the log books.

Stability

• To conduct analysis of stability samples and prepare stability reports.

Validation

• To validate the method developed and prepare validation report

Commercial Transfer

• Perform Lab to lab or Technology transfer of analytical method to the transferring site.

Documentation

• Prepare all documents related to Tech Pack for commercial transfer of the method.
• Maintain lab notebooks in proper condition and keep it updated at all times.

Safety

• To use PPE and follow safe practices in lab.

Job Title:Jr Research Scientist Analytical
Job Function: Innovation & Development
Location:Mumbai
Reporting to: Sr Group Leader Analytical
Critical Success Factors: Critical Success Factors (Competencies): Functional / Technical:
1. Development
o Is able to conduct the literature search for every product and derive an analytical profile that helps in method development and analysis
o Think in a scientific manner to develop analytical method and demonstrate practically with timelines
o Is able to support Formulators for pre-formulation studies using various analytical techniques
o Conducts the analysis on samples and provide the report within the timelines with no errors
2. Instrumentation
o Understands the working of basic instruments such as Balances, pH meters, UV Spectrophotometer, HPLC, etc to do calibrations
3. Validation
o Understands validation, prepares validation protocol and conducts validation studies & report within timelines
4. Stability
o Is able to conduct the Stability studies within specified timeline and with accuracy. Indicate and report the change in the stability profiles
5. Commercial Transfer
o Demonstrates the analytical method developed and transfers it without any issues to the receiving site
6. Project Management
o Is able to plan and prioritize multiple project deadlines to meet product delivery goals
7. Documentation
o Is able to write all documents based on the data from lab notebooks properly.
o Maintains lab notes for history and reference
8. Safety
o Understands the importance of PPE and practices the use of PPEs in the lab all the time (Personal Protective Equipment)
Education & experience:

• M. Pharm/Ph. D.
• 5-7 yrs of relevant experience in space of analytical development