Process Expert Technical Operations (MSAT) - API Production Sisslerfeld 100% (m/w/d) — Bachem AG
CHF 49'500 - 75'000
Bachem AG · Stein AG (AG)
- Location
- Stein AG
- Contract
- full-time
- Posted
- 22 days ago
SalaryCHF 49'500 - 75'000
Role overview
To advance our continuous organic growth, we are constantly looking for highly qualified professionals.
We are looking for a dedicated personality as a Process Expert Technical Operations (MSAT) API Production Sisslerfeld 100% (m/w/d)
As part of the development of our new Greenfield GMP-regulated downstream process plant for API production in Sisslerfeld, you work at the interface between production, quality, engineering and project management as well as other site functions and actively advance processes and structures.
- To advance our continuous organic growth, we are constantly looking for highly qualified professionals.
- We are looking for a dedicated personality as a Process Expert Technical Operations (MSAT) API Production Sisslerfeld 100% (m/w/d)
- Special responsibility for defining process requirements for downstream unit operations in cleaning and containment concepts, Contamination Control Strategies (CCS) and GMP-relevant risk analyses
- Support for scale-up evaluations and process evaluations as part of plant and process development
- Complete study of chemistry, pharmaceutical chemistry, biotechnology or a comparable technical or scientific discipline, ideally with doctorate
- Multiannual experience in large scale downstream or upstream processing of APIs in a GMP-regulated environment knowledge of preparative chromatography;
Main responsibilities
- Special responsibility for defining process requirements for downstream unit operations in cleaning and containment concepts, Contamination Control Strategies (CCS) and GMP-relevant risk analyses
- Support for scale-up evaluations and process evaluations as part of plant and process development
- Monitoring the commissioning of new plants and support in the implementation and establishment of production processes
- Construction and documentation of TechOps business processes in the course of location development
- Implementation of tech transfer equipment and creation and implementation of transfer plans
- Technical support for production in process questions and for analysis and processing of deviations
- Close cooperation with Manufacturing, TechOps, Engineering, QA and Project Management
- Support for government inspections and customer audits during setup and start-up
Key requirements
- Complete study of chemistry, pharmaceutical chemistry, biotechnology or a comparable technical or scientific discipline, ideally with doctorate
- Multiannual experience in large scale downstream or upstream processing of APIs in a GMP-regulated environment knowledge of preparative chromatography;
- Experience with freeze drying and spray drying
- Good knowledge of chemical production, process engineering, plant planning and regulatory requirements (e.g. ICH Q7, FDA, EMA)
- Experience in the planning and implementation of Tech Transfers
- Structured and solution-oriented operation and the ability to develop pragmatic solutions even in complex or unclear situations
- Team-oriented personality with clear, open communication and the ability to bring different interfaces together
- A dynamic and growing working environment with internal development and further training opportunities
- Flexible work time design with possibility for home office and option to cover additional holiday days with reduced workload Internal KITA at Bachem Campus Bubendorf
What the company offers
- Very good knowledge of German and English in word and writing Cosa offriamo
Additional details
- We are looking for a dedicated personality as a Process Expert Technical Operations (MSAT) API Production Sisslerfeld 100% (m/w/d)
- Multiannual experience in large scale downstream or upstream processing of APIs in a GMP-regulated environment knowledge of preparative chromatography;
- Good knowledge of chemical production, process engineering, plant planning and regulatory requirements (e.g.
- Very good knowledge of German and English in word and writing
- Flexible work time design with possibility for home office and option to cover additional holiday days with reduced workload Internal KITA at Bachem Campus Bubendorf
Notes and original content
- Descrizione
- We are looking for a dedicated personality as a Process Expert Technical Operations (MSAT)
- API Production Sisslerfeld 100% (m/w/d)
- Multiannual experience in large scale downstream or upstream processing of APIs in a GMP-regulated environment
- knowledge of preparative chromatography;
- ICH Q7, FDA, EMA)
- Cosa offriamo
- Flexible work time design with possibility for home office and option to cover additional holiday days with reduced workload
- Internal KITA at Bachem Campus Bubendorf
