Principal Extractable and Leachable Scientist

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Principal Extractable and Leachable Scientist, Parma

Client: Chiesi Group

Location: Parma, Italy

Job Category: Other

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EU work permit required: Yes

Job Reference: 61eb8a19f941

Job Views: 6

Posted: 18.06.2025

Expiry Date: 02.08.2025

Job Description:

Who we are looking for

Purpose

The Principal Extractable and Leachable Scientist will lead and manage extractable and leachable programs to ensure drug product safety and compliance. This role requires at least 5 years of experience in extractable and leachable testing, acting as a technical expert and guiding cross-functional teams.

Main Responsibilities

• Design and implement E&L strategies for multiple projects
• Develop and validate analytical methods for E&L testing
• Oversee E&L studies at CROs
• Draft, review, and approve testing protocols and reports
• Prepare safety assessment summaries for regulatory submissions
• Collaborate with suppliers and manufacturing to establish safety-based acceptance criteria
• Support regulatory interactions and responses
• Manage relationships with CROs and suppliers
• Communicate project status effectively within teams
• Stay updated on industry trends and regulations

Preferred Experience Required

• Experience with pMDI inhalers
• Experience with foreign particulate matter
• Experience with elemental impurities (ICH Q3D)

Education

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

Languages & Technical Skills

• Extensive chromatography and mass spectrometry experience (GC/MS, LC/MS, ICP/MS)
• Experience with extractable and leachable testing methods
• Knowledge of safety thresholds and best practices
• Understanding of GMP/cGMP and relevant guidelines (ICH, EMEA, PQRI, Health Canada)
• Familiarity with pharmacopoeia standards (USP, Ph. Eur.)
• Proficiency in data analysis software
• Ability to interpret analytical results and identify trends
• Knowledge of statistical methods (PCA, DoE)

Soft Skills

• Leadership and influence
• Planning and organization
• Problem solving and decision making
• Strategic thinking

What we offer

Join a dynamic, fast-growing, and supportive environment. We invest in continuous training and development, promoting work-life balance through flexible and remote working options, relocation support, and other people-centric services.