Dattatray Kauthale
Sr. Manager-ARD at Immacule Lifesciences ltd_ Complex injectables (Ex - Dr. reddys, Cipla, Wockhardt , Emcure, Macleods )
- Role
- Sr Manager-ard at Immacule Lifesciences
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Dattatray Kauthale
Total Experience:~19 Years • Regulatory Exposure: USFDA…
Experience
Sr Manager-ard
Aug 2019 — Present · Himachal Pradesh, IN
Injectable formulations -3 times USDA approved mfg plant• Led a 15-member team in injectable formulations development.• Successfully achieved more than 25 USFDA approvals for complex injectable products.• Developed complex peptide,oligonucleotides, PFS, Injectable suspension, lyophilized formulations and transferred them to large-scale production.• Conducted ICP-MS method development & validation for assay and elemental impurities per ICH Q3D guidelines.• Spearheaded QMS activities, including incident management, deviation handling, and change control.• Oversaw analytical activities such as diluent/admixture studies, photo stability, in-use study, freeze-thaw study, bulk hold study, and compatibility study.• Characterization of injectable formulation using viscometer, Particle size analysis, Dissolution studies.• Accountable for LIMS software activities, training through LMS, analytical data review, and approval.• Spearheading additional charge of new Immacule-2, ARD lab establishment and product development. Responsible for new instrument installation activity likes HPLC,UPLC,ICP-MS, Viscometer, Light microscope, microwave digestor, Balance, PH meter etc. Responsible for CSV activities of computer system.Experience of communicating to various CRO,CMO,MNC companies and big clients for successful product development and Cordination with F&D,QC,QA,RA depratemnt for efficient product filling.
Education
Vidyadham Prashala Devdaithan
Ssc
1999 — 2000
Ahmednagar Jilha Maratha Vidya Prasarak Samaj's New Arts,Commerce & Science College, Ahmednagar 414001
Msc.
2005 — 2007
Shirur Shikshan Prasarak Mandal's Shri Chandmal Tarachand Bora Arts, Science & Commerce College Shirur
BSc - Bachelor of Science
2002 — 2005
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