Drug Substance Analytical Lead

Date:  Feb 7, 2024
Department:  GTD Global Technical Development
Job Type:  Direct Employee
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Contract Type:  Permanent
Location: 

Parma or anywhere in Europe, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. 

 

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.  Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).

 

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.

Discover all our opportunities