Shire PKC Lead in Rieti (Baxalta), Italy

The PKC (Process Knowledge & Control) Lead, part of the PDTS (Process Development and Technical Services) organization, is responsible for executing Process Knowledge & Control activities in order to contribute to support manufacturing operations in their Life Cycle Management activities on manufacturing processes for phase III (Continued Process Verification - CPV) and commercial products.

He/She is in close contact with the Manufacturing/Quality organizations, with relevant process experts and with Global teams representatives. Key in this role is the development of robust monitoring plans that drive to becoming more pro-active. She/he will be responsible for:

  • Setup and maintenance of appropriate local monitoring system of in-process parameters and quality attributes for process monitoring, according to Global indications

  • Implementation and maintenance of site monitoring plans

  • Support and active participation in definition and implementation of Global initiatives concerning the PKC activities (Monitoring&Trending Harmonization, Process Knowledge System design, Yields monitoring Harmonization)

  • Support for local implementation and improvement of software for monitoring (Discoverant)

  • Compliance to cGMP’s, GDP’s, defining, implementing and maintaining appropriate SOP’s and training

Required skills and competencies:

  • Broad knowledge and experience within the GMP environment, Lean and SixSigma

  • High level of customer orientation and organizational skills

  • Flexible in mind / out of the box thinker, inclination to team work

  • Enthusiastic, motivating and convincing personality

  • Good knowledge of informatic tools

  • Fluent English

  • Good communication skills, verbal and written

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.