R&D Analytical Manager

1 mese fa

Roma, Lazio, Italia EUSA Pharma A tempo pieno
Job Title: R&D Analytical Manager

Join EUSA Pharma as a R&D Analytical Manager and lead our Analytical team in Method development and validation, Method Transfer and ICH stability studies for various stages of drug development.

Key Responsibilities:
  • Define the analytical strategy for new and ongoing projects to ensure all project work is effectively and efficiently delivered on time according to project schedule.
  • Prepare, review and approve protocols, reports and other associated project / GMP documentation ensuring the documentation are in compliance to internal and country specific regulations.
  • Manage internal team resources/schedules ensuring adequate planning and resource allocation for assigned development projects.
  • Identify technical problems/issues and develop solutions and fully implementing these solutions in agreement with Group Leader, Departmental Manager where appropriate.
  • Manage, supervise, and approve any analytical activities outsourced to external labs or Contract Development and Manufacturing Organization.
  • Ensure the R&D Analytical Laboratory is operated in a safe manner with full compliance to Standard Operating Procedures.
  • Implement and monitor systems/processes within the Laboratory to ensure cGMP compliance and drive change where required to improve systems and processes.
  • Take full responsibility for OOS/OOT/OOE investigations and ensure all investigations are conducted in a thorough and timely manner in accordance with procedures. Support Senior Analysts in setting investigation strategies and approve the design for investigations.
  • Provide support to QA department during Audits (internal/external) and promptly complete all assigned actions from audits.
  • Provide support (as required) to Regulatory department to respond to deficiency letters and to prepare the relevant documentation for dossier variation submission or scientific advice documentation preparation.
  • Actively participate in any assigned Team Project as Analytical SME.
  • Act as Due Diligence Advisor for CMC Module as required Prepare budget and review forecasts for analytical labs.
Required Skills and Experience:
  • +8 years proven track record in analytical team/laboratory management including experience in analytical development and validation Experience and knowledge in ICH guidelines, stability data management, and cGMP.
  • Proven experience in CMC pharmaceutical sciences focussed on analytical development.
  • Technical Competencies: Knowledge of analytical statistics tools and applications, perform trend analysis and evaluation.
  • Experience with analytical techniques for small molecules required, including UPLC/HPLC, GC, KF, UV/Vis, and IR. Particle size analysis, dissolution testing, DSC, TGA, and XRPD are a plus.
  • Knowledge of CMC regulation, with proven track record of deficiency letters management (analytical activities).
  • Knowledge in formulation development science is a plus.
  • Knowledge in LC/MS, Proteomics, and peptide analysis techniques and regulation is a plus.
Required Behaviours and Competencies:
  • Leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions.
  • Ability to successfully participate within extended, global multinational project teams and handle multiple challenges under pressure.
  • Self-directed and motivated.
  • Collaborative and good team player.
  • Excellent organizational and communication skills.
Required Languages:

Fluent English both spoken and written

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