Principal Extractable and Leachable Scientist

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.

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

The Principal Extractable and Leachable Scientist will be responsible for leading and managing extractable and leachable programs to ensure the safety and compliance of drug products. This role requires significant seniority and expertise, with at least 5 years of specific experience in extractable and leachable testing desired. The scientist will act as a subject matter expert and provide technical guidance to other scientists and cross-functional teams. This position plays a crucial role in advancing the company's mission to deliver safe and effective pharmaceutical products.

Main Responsibilities

1. Design and implement E&L strategies for multiple projects.
2. Develop and validate analytical methods for extractable and leachable testing.
3. Design and monitor extractable and leachable studies at CROs.
4. Draft, review, and approve extractable and leachable analytical testing protocols and reports.
5. Prepare extractable and leachable studies and safety assessment summaries for regulatory dossiers (IND, IMPD, MAA, NDA).
6. Collaborate with suppliers, commercial manufacturing division and toxicology to establish acceptance criteria for leachables and extractables based on safety thresholds.
7. Collaborate with commercial manufacturing to perform risk assessment of PERLS.
8. Support to commercial manufacturing division in answering questions from regulatory agencies.
9. Collaborate with R&D QA to select possible partners through appropriate technical/scientific evaluation in accordance with company quality requirements.
10. Manage relationships with CROs and supplier of CCS.
11. Communicate effectively with team members, cross-functional teammates, and non-technical audiences by openly sharing project status and hurdles while seeking input from other team members.
12. Stay updated with the latest industry trends and regulatory changes.

Preferred Experience Required

1. Previous experience with pMDI.
2. Experience with foreign particulate matter.
3. Experience with elemental impurities (ICHQ3D).

Education

Master's degree in Pharmaceutical Sciences, Chemistry, Biological Sciences, or a related field with 5+ years of related experience.

Languages

English fluent.

Technical Skills

1. Extensive experience of chromatography and mass spectrometry including GC/MS, GC/FID, LC/MS, ICP/MS.
2. Extensive experience of methods for extractable and leachable testing.
3. Deep knowledge of safety thresholds and best practices for extractables and leachables in drug products.
4. Deep knowledge of GMP/cGMP and guidelines (ICH, EMEA, PQRI, Health Canada) related to the pharmaceutical development of inhalation products.
5. Deep knowledge of international pharmacopoeia (USP, Phr EUR, etc).
6. Proficiency in relevant software and tools for data analysis and reporting.
7. Evaluate analytical results and identify trends, exceptions, and interpretations relative to chemical characterization, product requirements, and toxicological assessment.
8. Good knowledge of the univariate and multivariate (PCA, DoE) statistic.

Soft Skills

• Leadership and social influence.
• Planning and organizational skills.
• Problem solving.
• Decision making.
• Strategic thinking.

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.