Analytical Scientist Qc/cmc

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 QC/CMC**

**Monteresearch s.r.l -**Bollate (Milan Area), Italy

**The position foresees**:

- Finished product analysis for market release in accordance with relevant regulatory documentation.
- Certificate of analysis issue, data management and reporting, SOP issuing and review
- Review current approved analytical protocols and test procedures for new or revised regulatory requirements.
- Skills in method development HPLC/UHPL.
- Support performance targets for the laboratory, and monitor current performance against targets.
- Provide technical support to the pharmaceutical development team regarding issues which arise and are detected in the laboratory and also for trials which are performed as part of root cause investigation as support of senior scientists.
- Sharing of laboratory administrative tasks, such as ordering supplies, organizing maintenance schedules, organizing sample inventory, filing, organization of equipment instructions, if necessary.
- Willingness to learn new techniques and perform multiple tasks simultaneously

**Requirements**:

- Experience and knowledge in cGMP, ICH guidelines and stability studies management.
- 5+ years of experience in chemistry or pharmaceutical sciences in analytical development.
- Experience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, GC, KF, UV/Vis, IR. Particle size analysis, dissolution testing, DSC, TGA, and XRPD are a plus.
- Skilled in analytical management software ( i.e. Empower, Chromeleon),
- Knowledge in computer system validation is a plus
- Knowledge in LC/MS, Proteomics and peptide analysis technics and regulamentation is a plus

**Skills**
- Fluent English both spoken and written
- Self-directed and motivated
- Collaborative and good team player
- Strong organizational skills and communication skills

Contratto di lavoro: Tempo indeterminato

Retribuzione: €40.000,00 - €50.000,00 all'anno

Benefit:

- Buoni pasto
- Computer aziendale