Method Development & Validation Analyst ( Formulations)

This is a key role in the research and development area reporting to the R&D Team head, ensuring high standards of R&D analytical methods and formulations at all times.

This person will have 5 to 10 years of experience in analytical method development and validation

Responsibilities:

1. Develop and validate new R&D analytical methods (active, related substances and/or preservatives, Cleaning method) in line with ICH, EU, and other relevant requirements

2. Development and validation of analytical methods required for reverse-engineered development products. Development and validation of Elemental impurity method, Particle size methods or other analytical methods required during the development of a medical or veterinary Pipeline product.

3. Project management and coordination of all analytical activities associated with pipeline product development

4. Perform chemical and physical evaluation of R&D lab trials, optimization batches, and process validation batches and stability batches

5. Perform drug substance and brand leader sample characterization

6. Perform standardization of drug substance for preparing the secondary reference standards

7. Preparing the analytical test procedures, Stability Protocols, Method validation protocols and reports, method transfer protocols and reports, SOPs and stability protocols, and reports

8. Conduct and manage stability testing of the process validation and optimization batches and method transfer of the R&D finished product.

9. Assist data reviewer in the checking of R&D analytical data generated and maintain the instrument calibrations.

10. Ensure availability of the required standards/columns and reagents for R&D projects - Prepare responses to customer and Authority technical queries for analytical issues in coordination with the relevant formulator

11. Ensure analytical logbooks/experiment registers are completed regularly and maintained in line with GLP and company requirements.

12. Test trial samples from Formulators and provide the results as per the agreed timelines

13. Prepare and review Stability Reports

14. Update stability Testing reports as required

15. Conduct and manage analytical method transfer to QC laboratories or customer laboratories

16. Represent the company at the time customer audits or Authority inspections

17. Maintain R&D laboratory and analytical data and systems as per GMP and GLP requirements

18. Project manage and coordinate analytical activities assigned to you by management

Competencies (some examples below - add or delete as appropriate):

- Excellent analytical, reasoning and science skills

- Strong analytical science background

- Establishes strong working relationships with others, building team rapport and creating a cohesive

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