Drug Substance Analytical Lead

3 settimane fa

Parma, Italia Chiesi Group A tempo pieno
Who we are looking for Purpose

Support the analytical activities required for producing information and documentation suitable for preclinical and clinical development, and registration of new drug substances, including starting materials and intermediates, with particular focus on risk quality management in accordance with GMP/cGMP

Main Responsibilities

•    Supervise the testing activities on materials for non-clinical and clinical use
•    Study Monitor of analytical method development/validation/transfer studies
•    Study Monitor of stability studies
•    Study Monitor of drug substances characterization studies (e.g. forced degradation studies, solubility profiles, pKa, Log P/D,…)
•    Characterization of materials to support drug substance synthesis and process development studies
•    Critical quality attributes identification and control strategy definition
•    Contribute to select and qualify possible partners through appropriate technical/scientific evaluation
•    CROs/CDMOs management of the outsourced activities
•    Design and integrate analytical development strategy on new drug substances through a scientific risk-based approach to support non-clinical and clinical development
•    Collaborate to define the budget (costs and resources) of the assigned project
•    Promote the technological innovation, scientific understanding and best practices
•    Supervise the activities performed by laboratory technicians including any analytical non-confomity (deviations, OOS, OOT, OOE)
•    Preparation, revision and approval of technical, regulatory and GMP documentation
•    Promote operational excellence (processes/best practices) and continuous quality improvement
•    May contribute to scientific publications and presentations at conferences    
 

Experience Required

5-10 years as Analytical Scientist in manufacturing or pharmaceutical companies (new drug substances development)

Education

Scientific degree in Chemistry or a related field

Languages

Good English

Technical Skills

•    Knowledge of lean six-sigma methodology
•    Knowledge of the solid-state characterization of materials
•    Advanced knowledge of the spectrophotometric, diffractometric, calorimetric, potentiometric, mass spectrometry and chromatographic techniques
•    Advanced knowledge of the univariate statistics
•    Good knowledge of multivariate (PCA, DoE) statistics
•    Good knowledge of the standard informatic tools
•    Advanced documentation editing skills
•    Good knowledge of the business context in the pharmaceutical sector
•    Advanced knowledge of GMP/cGMP and guidelines (ICH, EMEA, FDA) related to the development of new drug substances
•    Advanced knowledge of problem solving, decision making and risk-management techniques

Soft Skills
  • Creative/innovative mindset
  • Decision making
  • Leadership and social influence
  • Goal orientation
  • Learning agility

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

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