Nivel cariera

Middle (2-5 ani), Senior (5-10 ani), Executive (>10 ani)

Limbi vorbite

engleză

Adresa/ adresele jobului

București


 MAIN RESPONSABILITIES

  • To execute and review data of the lab scale batch formula optimization, process optimization and help in trouble shooting in process development.
  • To ensure smooth technology demo to tech transfer team based on QbD and DoE approach.
  • Expert in handling all kind of formulation equipment at lab scale and at manufacturing scale and able to establish scale up calculation.
  • Process development by QbD approaches using structured DOE trials to develop robust process and its control that supports manufacturing of oral solid dosage forms.
  • Verify and receive projects from Development team for optimization and scale up at R&D and manufacturing locations.
  • Identification of Critical Process Parameters(CPP’s), Scale Dependent and Scale Independent parameters.
  • Conducting process FMEA discussion to identify the critical process parameter and risk mitigation.
  • Execution of Exhibit Batches at pilot scale and monitoring stability of the product.
  • Preparation, review and recommendations for Process Optimization report and PDR.
  • Application of scientific and engineering principles to develop process understanding and scale up from laboratory to commercial scale. (knowledge on PAT Tools like NIR, FT4, Malvern, Parsum Probe, DVS, ASAP).
  • Independently handling site transfer activities, Process validation batches.

CANDIDATE REQUIREMENTS

  • Higher education (pharmacy, chemistry).
  • Minimum 5 years experience in formula optimization, process optimization and help in trouble shooting in process development.
  • Experience in handling all kind of formulation equipment at lab scale and at manufacturing scale.
  • Experience in tech transfer based on QbD and DoE approach.
  • Knowledge on PAT Tools like NIR, FT4, Malvern, Parsum Probe, DVS, ASAP.
  • Knowledge of technology and pharmaceutical formulation for solid dosage forms.
  • 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.