Rajesh Wakaskar
CMC Drug Product Lead | Program Head | Tech Transfer | GMP Manufacturing
- Role
- Associate Director, Cmc Formulations & Manufacturing at Vertero Therapeutics, Inc
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Rajesh Wakaskar
Program lead for cross-functional focused teams to achieve pre-determined milestones for multiple molecules in the portfolio- Led timeline-sensitive activities for developing robust phase-appropriate, stable formulations with New Chemical Entities (NCEs) for clinical studies- Emphasis on the due diligence in setting up the right CDMO/CRO platform and managing actively the overall program scope while planning daily activities to meet the broader Program goals- Enhanced leadership role in authoring/reviewing the CMC sections of regulatory filings and liaising with internal/external stakeholders to ensure that the pertinent sections are ready for submission or any raised queries are duly addressed- Elaborate planning for some of the molecules entering into later phases of clinical trials to ensure that the appropriate formulation is locked in with due planning and execution of validation/registration batches- Drafted patent applications to secure intellectual property (IP) rights for multiple drug product formulations.
Experience
Associate Director, Cmc Formulations & Manufacturing
May 2022 — Present · Boston, MA, US
Education
University of Mumbai
Bachelor of Pharmacy (B.Pharm.), Pharmacy
University of Nebraska Medical Center
PhD, Pharmaceutical Sciences
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