R&D Analytical Scientist (Italia)

IQVIA LLC; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading global healthcare intelligence company in Milan is seeking an R&D Analytical Scientist to support analytical activities for drug product development. The successful candidate will develop and validate methods, manage stability studies, and ensure compliance with quality standards. Candidates should have at least 2-3 years of experience in a similar role within a pharmaceutical company or CRO, contributing to innovative healthcare solutions.

Competenze

• Minimum 2-3 years of relevant experience in the pharmaceutical industry or CRO.

Mansioni

• Support analytical activities for drug product development.
• Conduct stability studies and drug product characterization.
• Develop and validate analytical methods.

Conoscenze

Analytical methods development

Regulatory documentation review

cGMP standards

Quality Risk Management (QRM)

Descrizione del lavoro

R&D Analytical Scientist (Italia)

Apply locations: Milan, Italy   |   Full time |   Posted on: Yesterday |   Job requisition id: R1473849

Our client, Chiesi Farmaceutici, one of the top 50 pharmaceutical companies worldwide with over 80 years of experience in the pharmaceutical and biotechnology industries, is expanding its team. IQVIA is recruiting an Analytical Scientist to join an exciting, dynamic, and international environment.

Job Description:

Support analytical activities for preclinical and clinical development, registration of drug products, excipients, and intermediates, with a focus on quality in accordance with GMP / cGMP standards.

Responsibilities:

• Develop pharmaceutical products (small molecules, biological products, excipients, intermediates, Drug Products) following QRM principles, including designing and evaluating activities both internally and with CROs:
• Development, validation, and transfer of analytical methods
• Stability studies setup and management
• Drug product characterization studies
• Extractables and leachables studies
• Studies supporting formulation and manufacturing process development (feasibility, refinement, scale-up)
• Execute the development strategy for assigned projects

Contribute to scientific understanding in product development, prepare and revise technical documentation per quality and regulatory standards, and review regulatory documents (CTD/NDA, IMPD/IND, Q&A, Scientific advice briefing documents). Operate according to SOPs, cGMPs, safety guidelines, and policies. Support change control evaluations and quality investigations (deviations, OOS, complaints).

Requirements:

• At least 2-3 years of experience in a similar role within a pharmaceutical company or CRO.

Type of Contract: Permanent

IQVIA evaluates candidates based on domicile, residence, work experience, and education. Applications lacking the required qualifications will not be fully considered. Consent for data processing and transfer is required as per GDPR. This research is urgent and open to candidates of all genders.

About IQVIA:

IQVIA is a global leader in clinical research, commercial insights, and healthcare intelligence, dedicated to accelerating medical innovation and improving patient outcomes worldwide. We value diverse talent committed to innovation and impact, contributing to our mission of better healthcare for all.