Associate Director-API Development
- Djobs Hr Services
- 10 to 15 Yrs
- Hyderabad
- 3 years ago
- Email to a friend
- Report this job
Job Description
- 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, the establishment of API specifications, identification of impurities, and manufacturing.
- Provide technical support to CMOs for process improvements, new chemical syntheses, batch investigations, and deviations.
- Prepare technical reports and author API sections of regulatory documents such as INDs, IMPDs, and
- NDA/MAAs for global submissions.
- Evaluate and identify gaps in current and former program, develop remediation plans or additional studies that may be required.
- Interface with internal development teams, CMO project teams for timely execution of the plans.
- Interface with consultants to optimize chemistry processes and manufacturing strategies.
- Interface with legal, QA and regulatory consultants for ensuring compliance in the manufacturing of API under current GMP standards.
- Prepare product development updates and presentations as required.
- All other projects and responsibilities as assigned by the management and supervisor.
- Participate in the preparation of CMC department budget.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: R&D / Product Design
Functional Area: Not Applicable
Role/Responsibilies: Associate Director-API Development
Contact Details:
Company: DJOBS HR ServicesLocation(s): Hyderabad
+ View Contact
Fraud Alert to job seekers!
₹ Not Disclosed
Djobs Hr Services
Our client manufactures and supplies perimeter fencing made out of steel that defines our core competencyProduct- Steel Fencing & Wire Product for realty, Automatic fencing, Border fencing, agriculture fencing, Electric fencing
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in
