About the Company
Sun pharma is an Indian manufacturing pharmaceutical company with more than 40 manufacturing sites and more than 100 countries serving markets with more than 30000 employees and 2000 marketed products.
The company established in 1983 with 2-person marketing team and in 1994 launched and IPO. In 1991 it established an process development R & D center primarily. Now it has more than 2000 scientists.
The products include anti retrovirals, OTC drugs, API (Active pharmaceutical substances) urology, nephrology and so on.
About the Job
Opening for Pharmacokinetic Scientist
Experience : 5 - 10 years in Pharma industry
JD:
1. Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products(injectable, Semisolids, TDS etc.) towards different regulatory submissions.
2. Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols
3. Developing protocol for patient-based PK endpoint & also for PD/Clinical endpoint BE studies for complex generics.
4. Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software.
5. Coordinate with the CRO in India and outside India to finalize the biostudy pilot and pivotal study protocol for DCGI BE application.
6. Preparation of pharmacokinetic queries response, scientific justification for study design/ protocol/ results towards various regulatory agencies for their concurrence or advice.
7. Having an in-depth understanding of in-vitro parameters and identification of critical variables impacting the in-vivo release. Perform IVIVC, simulation and Pharmacokinetic modelling to improve BE success.
Send in your resume to : [email protected]
MS&T Manager:
Sun Pharmaceutical Inds Limited - Baroda
Position: Manager – MS&T Oral Solid
Job Location: Halol (Gujarat )
Qualification: M.Pharm
Brief JD :
The person will be Responsible for driving below activities of MS&T.
1) Exhibit Projects, New Launch Projects and Troubleshooting Projects
2) To coordinate with different departments i.e. Formulation Development, Production, Engineering, Quality Control, Quality Assurance, Packaging and any other for the timely execution of the projects.
3) To keep track/plan & monitor for the Trial, Scale up and Exhibit & Pre PV/PV Batches.
4) To review/approve documentation i.e. trial batch objective, trial batch BMR, protocol, report, justification / technical report / regulatory query response/write-up for any recommendation/data compilation/study protocol/report etc.
5) To attend / plan meetings for moving forward the projects.
6 ) To assist the CFT (Production / QA / QC etc department) for resolving the troubleshooting Projects, Trial / Scale Up Batches manufacturing / EB / CH / PV Batches manufacturing.
7) To initiate/ review/ evaluate Investigations.
Send in your resume to : [email protected]