Analytical Scientist CMC

About the company:

Tutti i candidati sono invitati a leggere attentamente la seguente descrizione del lavoro e le relative informazioni prima di candidarsi.

Since 1997 Monteresearch has been at the forefront of pharmaceutical R&D, designing and optimising advanced drug-delivery technologies that go “Beyond the Standard of Care.” Today we operate a purpose-built 1,800 m² GMP-qualified site near Milan and sit within EMS (NC Group) – Brazil’s largest pharmaceutical company – giving our teams the agility of a specialised lab and the resources of a global network.

Our mission is to transform bold scientific concepts into market-ready therapies for unmet medical needs, with a focus on repositioning small molecules, oral peptides and oligonucleotides.

End-to-end in-house capabilities span formulation and analytical development, IMP manufacturing, clinical supply, regulatory CMC, and pivotal trial management, allowing scientists to see their ideas progress from benchtop to first-in-human studies under one roof.

Monteresearch is also the GMP analysis and release bridgehead to European market for EMS specialty and primary care products.

Joining Monteresearch means collaborating in an environment that values scientific rigour, innovation and a strong sense of belonging. You will work alongside multidisciplinary experts who share a commitment to reliability, quality and patient-centric solutions, backed by the stability and growth prospects of an international group.

If you are driven to shape the future of drug delivery and make a tangible impact on global health, we invite you to explore the opportunity below.

The open position we offer is:

Analytical scientist CMC

Monteresearch s.r.l Milan Area, Italy

The position foresees:

·        Provide technical support to the pharmaceutical development team regarding analytical method development and validation, as well as support for issues arising in the laboratory and during trials performed as part of root cause investigations.

·        Review and issue analytical protocols and test procedures in accordance with new or revised regulatory requirements.

·        Develop and validate analytical methods for new products in the development pipeline, including stress testing execution and risk assessment activities.

·        Support laboratory performance targets and monitor current performance against defined objectives.

·        Manage Certificate of Analysis issuance, data management and reporting, as well as SOP drafting and review.

·        Perform finished product analysis for market release in accordance with relevant regulatory documentation, and support investigations as required.

·        Share laboratory administrative tasks, such as ordering supplies, organizing maintenance schedules, managing sample inventory, filing, and maintaining equipment documentation when necessary. xdwybme

·        Demonstrate willingness to learn new techniques and manage multiple tasks simultaneously.

Key Responsibilities

·        Analytical method development and validation

·        Execution of stress testing and stability-related activities

·        Analytical troubleshooting and root cause investigation support

·        Preparation and review of analytical documentation (protocols, reports, SOPs)

·        Data management and integrity compliance

·        Support of laboratory KPIs and continuous improvement

·        Collaboration with cross-functional teams

Requirements

·        Proven track record in applying analytical techniques to solve complex problems

·        Strong knowledge of cGMP, ICH guidelines, and stability study management

·        Minimum 5 years of experience in chemistry or pharmaceutical sciences within analytical development

·        Experience with analytical techniques for small and large molecules and solid dosage forms, including HPLC/UPLC, GC, KF, UV/Vis, IR

·        Experience with particle size analysis, dissolution testing, DSC, TGA, and XRPD is a plus

·        Proficiency in analytical software (e.g., Empower, Chromeleon)

·        Knowledge of computer system validation is a plus

·        Knowledge of LC/MS, proteomics, and peptide analysis techniques and related regulations is a plus

Skills

·        Fluent English (both written and spoken)

·        Self-directed and highly motivated

·        Strong team player with collaborative mindset

·        Excellent organizational and communication skills

What we offer:

Salary income: 40.000– 50.000 €

Hybrid remote work according to company policies