Dhara Patel
Manager | Biologics, Analytical Method Development, Bioequivalence strategy planning, Quality and Regulatory compliance, Product development, Project management, Pharmaceutical Analysis Track committee AAPS
- Role
- Manager Quality Control at Kashiv BioSciences LLC
- Location
- North Brunswick, NJ, US
- LinkedIn followers
- 500 followers
About Dhara Patel
A skilled Principal Scientist with 13 years of diverse experience in Pre formulation, Analytical R&D, Quality management systems and In vitro bio equivalence. I am dedicated to pushing the boundaries of scientific discovery and regulatory compliance.Strong expertise in developing and validating robust analytical methods, driving innovative product development strategies for complex products. Skilled in designing In-vitro skin permeation testing, In-vitro drug release testing and physical characterization testing for Bio waiver approach. Demonstrated expertise in managing large-scale external collaborations, from vendor selection to project execution, ensuring alignment with R&D goals and regulatory standards.Managed and handled multiple FDA on-site Inspections successfully, demonstrated challenging analytical techniques to FDA during FDA’s education tour.Skilled in creating thorough and scientific responses to FDA inquiries. Providing scientifical justifications and rationales in the response of FDA queries, DRLs, IRs, CRs.Proficiency in cGMP, cGLP working principles.Expertise in handling and management of DEA CDS controlled substances (CII- CV).
Experience
Manager Quality Control
Feb 2026 — Present
Education
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy (BPharm), Pharmacy
2005 — 2009
Long Island University
Master's degree, Pharmaceutical Sciences
Skills
- Drug Delivery
- Pharmacokinetics
- Uv
- Pharmaceutics
- Differential Scanning Calorimetry
- Hplc
- Uv/Vis
- Dmpk
- Bioanalysis
- Lc-Ms
- Regulatory Affairs
- In Vitro
- Animal Work
- Dissolution
- Anda
- Analytical Chemistry
- Franz Diffusion Cell
- Gmp
- Analytical Method Validation
- Glp
- Chromatography
- Validation
- Formulation
- Ir
- Drug Development
- R
- In Vivo
- Pharmaceutical Research
- Tlc
- Sop
- Pharmaceutical Industry
- Research
- Gas Chromatography
- Abuse Deterrent Formulation
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