Senior Bioanalytical Scientist

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 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.

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, global technical development, 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), Toronto (Canada) and Shanghai (China).

 

Who we are looking for

Purpose

• Accountable for providing high quality bioanalytical methods across projects.
• Direct bioanalytical activities related to clinical pharmacology and biomarker studies within clinical development programmes, to ensure delivery of study results within specific timescales and quality.

Main Responsibilities

Planning and organization of outsourced bioanalytical activities, including management of external bioanalytical partner laboratories and complying with Chiesi SOPs and standards and Chiesi Group objectives.
• Manage transfers and validation of bioanalytical assays for PK, PD and immunogenicity assessments of biotherapeutics (e.g., ELISA, ECL, large-molecule LC-MS); supervise development and assay optimization
• Support clinical teams to set up the clinical trials by providing bioanalytical input for instance on sample collection and bioanalytical methods
• Coordination of the timely analysis of biological samples from clinical studies at external bioanalytical laboratories, including result reporting, data interpretation, data transfer as well as review and/or creation of bioanalytical plans, reports and method SOPs for bioanalytical sample analysis
• Monitor outsourced activities at 3rd party during the course of the studies; support the external lab during trouble-shootings
• Support creation of international registration documents and interact with authorities (where appropriate )
• Participation in project teams as well as presentation of updates / results of bioanalytical activities whenever needed.
• Develop Immunogenicity analytical clinical strategy based on drug candidate's immunogenicity risk assessment.
• Leverage advanced analytics to validate biomarkers and support their integration into clinical trials, ensuring alignment with regulatory requirements for pharmacodynamic, predictive, prognostic, and diagnostic use

Experience Required

At least 5 years of hands on or oversight experience in pharmaceutical company or CRO 

Education

Degree in Chemistry, Biology, Biotechnology or similar. 

Languages

English fluent

Technical Skills

Extensive expertise in bioanalytical method development and validation for both small and large
molecules, as well as biomarkers—including immunogenicity assays—with in-depth
understanding of clinical immunogenicity data interpretation and regulatory requirements

Soft Skills

• Analytical skills
• Planning and organizational skills
• Team working
• Communication skills

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