Drug Substance Analytical Lead

2 settimane fa

Roma, Lazio, Italia Chiesi Farmaceutici S.p.A. A tempo pieno
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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

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

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

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