Kandarp Vashi

Kandarp Vashi

Project Manager @Ardena

New York, NY, US
EMAILS
k••••••••@ardena.com
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Feb 2025 — Present

Project Manager @Ardena

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Somerset, NJ, US

Directed over 10 global drug development programs, ensuring regulatory compliance and seamless CMC execution. • Developed integrated project strategies that aligned cross-functional teams with corporate objectives. • Acted as the primary client liaison, translating complex program progress into actionable strategies.

EDUCATION

N/A

Northeastern University

Master of Science - MS, Pharmaceutical Sciences

2009 — 2013

Gujarat Technological University (GTU)

Bachelors, Pharmacy

N/A

Rutgers Business School

Master of Business Administration - MBA, Strategy and Supply Chain Management

N/A

Northeastern University

Master of Science (MS), Pharmaceutics and Drug Delivery Systems

N/A

Northeastern University

Master of Science - MS

SKILLS

TlcDrug DeliveryWestern BlottingR&DMicrosoft WordDnaGlpFormulationPharmaceutical IndustryHplcCleaning ValidationPolymerase Chain Reaction (Pcr)Cell TransfectionAffinity ChromatographyProteomicsResearchLife SciencesHigh-Performance Liquid Chromatography (Hplc)TransfectionGmpPaper ChromatographyLaboratoryPowerpointMicrosoft ExcelProcess ValidationNew Product ValidationElisaLaboratory SkillsPcrThin Layer ChromatographyBiotechnologyPharmaceuticsDrug DiscoveryBiochemistryMicrosoft Office

ABOUT KANDARP VASHI

Results-driven Project Manager with a proven track record of leading multi-site, cross-functional teams in the pharmaceutical industry. Specializes in managing drug product development projects, overseeing the progression from early-stage formulation through to commercialization, ensuring full compliance with global regulatory filings (NDA, ANDA, IMPD, DMF) in the U.S, EU, and JapanExtensive expertise in Pharma manufacturing (API, liquid dosage forms, and oral solid doses) with a strong focus on customer advocacy within CDMOs/CMOs. Adept at strategic project planning, risk mitigation, and leveraging PM tools to optimize efficiency, track KPI data for key milestones, and accurately forecast revenue to drive business success.Highly skilled in stakeholder alignment, team facilitation, and cross-functional collaboration. Passionate about solving complex challenges, fostering partnerships, and bringing innovative therapies to market while maintaining a focus on quality, efficiency, and regulatory excellence.

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