Supervisor - Analytical R&D

Location US-NJ-Bridgewater
Posted Date 1 month ago(2/9/2018 2:36 PM)
Kashiv Pharma LLC.


Kashiv Pharma, LLC. is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.



Analytical Supervisor will manage an analytical team to support product development. Conduct method development, method validation, sample testing in support ANDA and NDA submission. Ensure the analytical laboratory activities are in compliance with requirements of FDA and the other regulatory agencies.


Essential Duties & Responsibilities


Key responsibilities of the position include, but are not limited to –


  • Manage an analytical team to support both NDA and ANDA projects.
  • Support formulation development.
  • Supervise and conduct the method development, method validation, RLD, characterization, sample testing.
  • Generate, review, and approve all supporting document including protocols, reports, test methods, specifications and other in support of the ANDA and NDA filing.
  • Support the excipients and packaging components release.
  • Ensure all analytical are in compliance with FDA and other regulatory agencies requirements.
  • Support pre-formulation activities.
  • Direct the training and development staff.
  • Ensure all project timelines and milestones are met.
  • Performs other functions as required or assigned
  • Complies with all company policies and standards


  • Masters with minimum 4+ years experience or
  • Ph.D. with minimum 2+ years experience in Analytical R&D


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