Scientific Associate in Clinical Manufacturing Unit
vor 13 Stunden
**About Idorsia Pharmaceuticals Ltd**
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bring R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1000 highly qualified specialists dedicated to realizing our ambitious targets.
We are looking for an enthusiastic and motivated **Scientific Associate** to join our Clinical Manufacturing Unit for Solids
**Responsibilities**:
You integrate our multipurpose clinical manufacturing units for Development and manufacturing of Solids dosage forms.
The pilot scale manufacturing unit is designed for the preparation of tablets, minitablets, capsules, pellets for supplying clinical studies from early stage development to late stage approaching commercial.
**Role and responsibilities will include**:
- Formulation, manufacturing process development and Clinical Trial Material manufacturing
- Manufacturing of development batches including scale up from small to pilot scale
- Manufacturing and supply of clinical batches according to cGMP for phase I to III clinical studies.
- Clean operational areas and equipment according to SOPs
- Development plan proposal, protocol writing in collaboration with the responsible Formulation Development Manager
- Support in issuing master batch records, preliminarily development reports
- SOPs writing and maintenance
- Support internal and external Quality inspections
- Collaboration with other disciplines such as Preformulation and Preclinical Galenics, Project Management, Quality Assurance, compliance team, Quality Control and Clinical Trial Supply to ensure that operations are planned in an efficient manner.
- Purchase and management of facility consumables
- Support investigations related to troubleshooting such as deviations, change controls, out of trend data, CAPAs
- Support supervision of unit installations and follow-up on safety regulations with Health & Safety department
- Bachelor degree in a relevant field with at least 3 years of experience in drug product formulation development / clinical trial material manufacturing field (Formulation development processes, QbD approaches or cGMP Drug product manufacturing and control)
- Excellent team working skills
- Be able to work closely with different stakeholders in a matrix environment
- Well-developed planning and organization skills
- Fluent in English (German or French would be an advantage)
**What Idorsia offers**
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution-oriented environment where you can make a difference
- An innovative and open culture in a truly multicultural environment
- A competitive salary and generous benefits
- **Work Location**:Basel Area - Allschwil
- **Country**: Switzerland
- **Business Area**:Pharmaceutical Development - GMP Clinical Manufacturing Units
- **Schedule**:Fulltime
- **Job Type**:Permanent
- **Job ID: 3812
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