Advanced Scientist L. 68/99 Lazio

Advanced Scientist L. 68/99
Roma
Lazio, Lazio

Your role: The "Global Analytical and Pharmaceutical Scientific Innovation" Department / "Analytical Regulatory and CMC Science" Unit is providing Regulatory support and coordination on analytical topics (HAs queries, renewal, compliance GAPs), including improvement in pharmacopoeial compliance, and support improvement in the quality of the analytical documentation for biological products (mAbs, recombinant proteins, fusion proteins, ADCs).

It is also proactively monitoring new analytical requirements by Regulatory Authorities and cross check discrepancies among different pharmacopoeial requirements, ensuring that methods, technologies, and validation are compliant/aligned to latest regulatory expectation.

Finally, it is providing Scientific support through matrix interaction with different Functions (including BR-CMC, R&D, MBQ).

The candidate will support all these activities in the physico-chemical field analytical methods for QC purpose (development, validation and in routine activity) and physico-chemical characterization for both early Phase, late Phase, and marketed products.

In particular, the candidate will have the following responsibilities: coordination on analytical topics for Regulatory submissions and AtOs, review and drafting of Regulatory dossiers, promote harmonization of file requirements, both new registrations and changes, actively support Regulatory implementation of LCM changes, identify and communicate implications for analytics of pharmacopoeial updates, provide technical and scientific expertise as member of inter-functional teams and identify gaps, plan action, drive & monitor mitigation execution to ensure methods, technologies and validation are compliant/ aligned to latest regulatory expectation.

Who you are: Degree in Life Science is required (Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Chemistry, or equivalent) Several years of experience in senior roles of analytical development and validation.

Strong knowledge of regulatory requirements.

An experience in physico-chemical characterization method is a plus Demonstrated ability to collaborate and negotiate solutions in a matrix environment and interacting with different functions/stakeholders in the organization Problem solving skills Excellent skills in writing, oral, interpersonal communication, and presentation (English) #J-18808-Ljbffr