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