Associate Director API Development
- Djobs Hr Services
- 12 to 21 Yrs
- Hyderabad
- 3 years ago
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Job Description
DJOBS HR Services _hiring for Associate Director API Development MNC Company
Profile : Associate Director API Development
- Required qualification & experience MS / PhD chemical engineering. Excellent command on English. MNC / Global experience is preferred.
- Salary expectation no bar.
- 12 + years experience is compulsory in process development, manufacturing or contract manufacturing role.
Responsibilities:
- Management of day-to-day activities of API development and manufacturing at CMOs. This includes: chemical process development and optimization, synthesis and qualification of reference standards, establishment of API specifications, identification of impurities, and
- Support technology transfers of APIs from one supplier to new suppliers on a global
- Provide technical support to CMOs for process improvements, new chemical syntheses, batch investigations and
- Prepare technical reports and author API sections of regulatory documents such as INDs, IMPDs, and NDA/MAAs for global
- Evaluate and identify gaps in current and former program, develop remediation plans or additional studies that may be
- Interface with internal development teams, CMO project teams for timely execution of the
- Interface with consultants to optimize chemistry processes and manufacturing
- Interface with legal, QA and regulatory consultants for ensuring compliance in the manufacturing of API under current GMP
- Prepare product development updates and presentations as
- All other projects and responsibilities as assigned by the management and supervisor.
Participate in the preparation of CMC department budget
If anyone interested share the update resume pr**********s@gm**l.com
contact number :9131619***
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Bio Tech / R&D / Scientist
Functional Area: Not Applicable
Role/Responsibilies: Associate Director API Development
Contact Details:
Company: DJOBS HR ServicesLocation(s): Hyderabad
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₹ 9 - 18 Lakh/Yr
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