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.
Gene Therapy has the potential to develop transformational medicines to treat a number of diseases and we at Shire are investing significantly in the development of an innovative Gene Therapy group.
The responsibilities of the role include:
- Planning, execution, documentation and reporting of formulation development studies such as pH solubility screens, stress studies (Temperature, Light, Shaking) and stability studies
- Planning, execution and documentation of process development and optimization studies such as those involving the fill/finish activities
- Implementing Formulation and Process Development methodologies on the High Throughput platforms
- Supporting Tech Transfer and scale -up activities for drug product manufacture
- Authoring and reviewing the CMC sections of regulatory documents
- Serving as the formulation development expert on matrix cross-functional project teams
The ideal candidate for the Senior Scientist (m/f) position would bring
significant Formulation Development experience in the field of gene
therapy and protein-based biopharmaceuticals coupled with the capability
for innovative thinking across the CMC space to develop
transformational medicines to treat a broad cross section of diseases.Qualifications
- A PhD degree in Biology, Biochemistry, Microbiology, Pharmaceutical Sciences or related discipline would be ideal
- Experience in drug product development in gene therapy and/or protein based biopharmaceuticals/vaccines
- Openness to embracing new technologies and new scientific advances and implement them in the group?s work
- Genuine desire and passion to make a significant contribution to understanding and leading the drug product development solutions within Gene Therapy and Coagulation factors
- Excellent communication skills, with a proven ability to communicate to both senior management as well as team members, along with the ability to foster strong external relationships with collaborators and partners
- Ambition and desire for success and personal growth
- To fulfill the role with success, you need to be a team player who can work independently or as a collaborative member in a technically and culturally diverse team
Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 3,008.38 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. Company Insights: https://www.youtube.com/watch?v=Ke-L4TZOujs