Manufacturing Process Specialist

2 giorni fa


Roma, Lazio, Italia Takeda Pharmaceutical A tempo pieno

Job Description

Main Activities and Duties:

  • Provide technical support with regards to manufacturing processes, investigations, optimization, yield, improvement projects, and cycle time reduction.
  • Support and/or perform investigations and assessments related to the processes, including troubleshooting and problem solving.
  • Identification/support and management of yield improvement projects, cycle time reduction, and process robustness initiatives.
  • Participation in risk assessment within changes (e.g., pFMEA).
  • Provide technical support with regards to manufacturing processes and participate in internal and/or external functional/multifunctional teams.
  • Support the preparation of regulatory submission/meetings and support regulatory inspections and defending technical decisions to regulatory agencies.
  • Consult technical documentation in the archive and support small-scale trial activities in Lab Scale.

Behavioural Competencies and Skills:

  • 3-5 years of experience in the multinational or consolidated medium-large pharmaceutical industry.
  • Strong ability to communicate effectively technical material in written and oral English.
  • Statistical knowledge, digital-oriented, data analysis mindset, and capacity to drive conclusions based on data.
  • Knowledge of data analysis tools (e.g., MINITAB, SIMCA).
  • Be positive and accountable, results-oriented, and precise, with good self-management and prioritization skills.
  • Good team player/leader with both practical and theoretical knowledge of the purification of plasma proteins.

Education:

  • Master or PhD degree in technical/scientific education, preferably pharmaceutical sciences, chemistry, biochemistry, biotechnology, or pharma-process engineering.
  • Knowledge related to GMP-requirement.
  • Desired skills include Six Sigma and DMAIC.

Additional Information:

  • Regular decision-making on events with low to moderate criticality, evaluating impact, defining characterization tests, and collaborating on PFMEA preparation.
  • Decisions to be escalated for topics with high criticality.


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