Senior Manager
Posted on :
23-07-2024
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Job Description
Description:
1. Ph.D. in Organic Chemistry from a reputed university.
2. More than 05 years of industrial experience in API R and amp; D from a reputed pharma company.
3. Have adequate knowledge of Regulatory requirements DMF preparation and regulatory filings.
4. Ensure the proper documentation practices report preparation and the ability to present the
development activities
5. Have the ability to work with multiple projects and timely deliverance.
6. Worked for process improvement cost reduction vendor approval plant troubleshooting and
Investigation of failures
7. Sound knowledge of IPR regulatory filing requirements Genotoxic impurities NNitroso
impurities identification and control requirements
8. Ability to design noninfringing costeffective and amp; scalable synthetic routes.
9. Scientific knowledge of developing robust and safe processes for desired quality API.
10. Current Good Laboratory Practices.
11. Awareness of Laboratory Safety.
12. Purge studies for specification fixation of key starting materials intermediate and Raw
materials.
13. Endtoend product development cycle from lab scale to commercial Scale.
14. Thorough understanding of critical process parameters.
Responsibilities:
Requirements:
Employment Type
Full Time
Company Industry
Key Skills
- Program Management
- FDA Regulations
- Management Experience
- Compliance Oversight
- Clinical Development
- Data Management
- Quality Systems
- Project Management
- Research and Development
- GLP
- Budget Development
- Leadership Experience
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