Sr. Scientist AR&D

Location US-NJ-Bridgewater
Posted Date 1 month ago(2/9/2018 2:35 PM)
Kashiv Pharma LLC.



Kashiv Pharma is an emerging pharmaceutical research and drug delivery company focused on developing innovative technology platforms and novel drugs with clinical differentiation and a compelling value proposition for patients, physicians, and payers. We have developed a portfolio of proprietary drug delivery technologies to improve the efficacy, safety, compliance, and dosage of low bioavailability drugs where absorption could be limited due to solubility, permeability, and stability problems. Our approach is to understand market needs and develop innovative medicines to improve health outcomes. The pipeline consists of novel drug formulations for preventing drug abuse or misuse, and in improving treatments for severe debilitating diseases. We plan to commercialize our products through licensing, or partnering, or through the creation of our specialized internal commercialization infrastructure. 


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


  • Develop and validation analytical method for drug substances, drug products, and excipients
  • Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.
  • Write protocols, reports, methods, standard operation procedure, and submission documents.
  • Provide analytical support for formulation and process development.
  • Perform independent scheduling and coordination of activities
  • Conduct instrument troubleshooting.
  • Analyze analytical data, identify trends and provide recommendation.
  • Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings
  • Train and provide technical guidance to junior scientists.
  • Conduct laboratory investigation and prepare laboratory investigation report.
  • Proactively provide Lab management with suggestions on how to improve the methods, lab practice or lab system.
  • Evaluate and improve existing test methods
  • Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.
  • Perform other job related duties as assigned.


Position Requirements and Qualifications

Education and Experience

  • PhD. in analytical chemistry or related discipline with minimum 5+ years’ US pharmaceutical experience or M.S. with minimum 8+ years experience.

Specialized Knowledge and Skills


  • Posses broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies
  • Good understanding of USP methodologies, ICH Guidelines, cGMP and FDA regulations.
  • Hands on experience in wet chemistry techniques.
  • Good verbal and written communication skills.
  • Attention to details and accurate record keeping.
  • Ability to plan, schedule and work independently in a fast pace environment. Self-motivation, adaptability, and a positive attitude.
  • Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
  • Ability to work under pressure and meet deadlines

Work Environment & Physical Demands


General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Some travel may be involved.




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