Nivel cariera

Senior (5-10 ani), Executive (>10 ani)

Limbi vorbite

engleză

Adresa/ adresele jobului

București


MAIN RESPONSABILITIES

  • Reverse engineering of the drug product
  • Develop discriminatory dissolution method and provide insight on IVIVC
  • Expert in handling and interpretation of analytical instruments like DSC, TGA, DVS, pXRD, Raman, HPLC, UPLC, Fiber optic dissolution testing, Intrinsic dissolution rate
  • Analytical Method development skills (Assay, RS, Dissolution), Method validation as per ICH
  • Hands on Deficiency responses
  • Well verged with GMP practices and faced audits
  • Support on alternate API source qualification
  • Knowledge in Impurity synthesis by preparative HPLC, able to isolate and characterize any unknown degradation Impurity with the help of mass, NMR, IR techniques

 CANDIDATE REQUIREMENTS

  • Higher education (pharmacy, chemistry)
  • Minimum 5 years experience in analytical development
  • Experience in handling all kind of formulation equipment at lab scale like DSC, TGA, DVS, pXRD, Raman, HPLC, UPLC
  • Experience in working with English documentation (translation, communication, written / verbal documentation)
  • PC operation (Word, Excel, Internet, email communication)
  • Ability to analyze and attention to detail
  • Relative skills for finding solutions of common interest in departments and working groups
  • Initiative and new survey on the subject