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Analytical Bio Project Principal Scientist

2 settimane fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 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 analytical development, validation and transfer of methods as well as characterization of biotechnology derived products.

Collaborate closely with internal experts and external CDMO partners.

Tasks will range from early-phase method development to late-stage analytical support of product approaching market approval.

Main Responsibilities

Responsible for development and validation of analytical methods mostly in collaboration with CDMO

Responsible for the biological characterization of the recombinant proteins in collaboration with relevant CRO's

Write protocols, reports, SOPs and technical documentation

Provide expert analytical support in cross-functional projects and work streams

Ensure all work is performed in accordance with industry standards, guidelines and regulatory requirements

Ensure appropriate reporting and documentation of activities and project progression. Provide technical and science-based solutions to projects.

Supporting regulatory documentation and contributing to quality assurance

Experience Required

At least 5 years' experience from the biotechnology industry

Extensive expertise within protein analysis and characterization

Experience of development, validation and transfer of analytical methods

Experience of Bioassay method development and validation is valuable

Experience from regulatory controlled work/processes

Broad general experience in adjacent fields for the development of biopharmaceuticals

Education

Degree in Analytical Chemistry, Biotechnology or similar

Languages

Strong written and spoken English

Soft Skills
  • Analytical skills
  • Planning and organizational skills
  • Problem solving
  • Quality orientation
  • Team working

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.