Shire is the new world market leader in rare diseases with more than 50 rare diseases products and programs including select pre-clinical programs within the development pipeline. At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeuticareas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
The Head of Process Implementation Experts, as part of the Non-GMP Pilot Plant Operations organization, is leading a team of Process Experts for biological molecules and in charge of the following tasks:
- Providing process and product expertise to development programs in various stages
- Tech transfer of the process from development to pilot plant and/or GMP manufacturing (Ph I/II to Ph III)
- Providing technical support including on-floor support during clinical production of biologics/gene therapy products
- Contributing actively to risk assessments, deviation and GMP investigations, and drafting regulatory submissions
This team will interact closely with drug substance process development teams, the technical services teams, and manufacturing network to ensure seamless process/knowledge transfer and manufacturing support at all development stages.Qualifications
- University Degree in Natural Science e.g. Biotechnology, Molecular Biology
- More than 10 years of experience in biopharmaceutical industry
- Experience leading diverse global teams
- Strong background in QbD development and manufacturing principles
- Strong quality, regulatory, and cGMP knowledge
Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 4,000.- gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field.