Head of TS External Manufacturing

Shire plc   •  

Lexington, MA

11 - 15 years

Posted 242 days ago

This job is no longer available.

The Head of Technical Services External Manufacturing, part of the PDTS (Process Development and Technical Services) organization,  is responsible for providing guidance and technical support to the External Manufacturing Organisation. He/She is making the liason between the Technical Process Experts and the CMOs, and ensures to define and prioritize the on-going developments/improvements, and problem solvings. Key in this role is to ensure adequate process/product support to ensure uninterrupted supply.

ESSENTIAL RESPONSIBILITIES:

1.Assure process robustness/harmonization and supply reliability by controlling the manufacturing process life cycle and authority submission to routine production

2.Responsible for providing a reliable yield status (actual data) and accurate yield forecasts for all plasma products together with strategies to meet the yield targets

3.Ensure adequate process support on site at the manufacturing site

4.Provide Technical Training support

5.Support TT Execution

EDUCATION AND EXPERIENCE:

  • Master or PhD degree in technical / scientific education, preferably biochemistry, biotechnology or pharma – process engineering is essential
  • At least 10 years professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology

KNOWLEDGE, SKILLS AND ABILITY:

  • Broad knowledge and experience within the GMP environment, Lean  and SixSigma and regulatory affairs
  • Very strong and proven leadership experience and capability
  • Very successful track record of change management projects and processes
  • High level of customer orientation and organizational skills
  • Flexible in mind / out of the box thinker
  • Enthusiastic, decisive, motivating and convincing personality
  • International background appreciated
  • Excellent communication skills, verbal and written communication skills

Req ID: R0020189