Senior MSAT Engineer 100% (f/m/d). Visp, CH
Bacthera is leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.
For our site Visp / VS Switzerland we are seeking a proactively, goal-oriented and open minded:
Senior MSAT Engineer 100% (f/m/d)
Act as MSAT Process Expert within the Bacthera end-to-end MSAT organization from pre-clinical development to commercial production. Contribution to successful transfer, scale up, process monitoring and optimization of Live Biotherapeutic Product (LBP) processes in the MC4a facility in Visp. Is accountable for the performance and results of the assigned area. Is member of MSAT Team.
- A Master (minimum) or PhD degree in a relevant life science or engineering field or similar
- Min. 5 years’ experience in the GMP regulated pharmaceutical industry, preferably in microbiologic sector
- Recognized expert in the area of GMP and biopharma production
- Strong leadership skills in matrix organizations
- Excellent collaboration and communication skills
- strong business understanding
- Proactive, solution-oriented team-player
- Open-minded for new ideas in a fast changing environment
- Experienced in, and comfortable with Health Authority GMP inspections (e.g. Swissmedic, US-FDA) and customer audits
- Fluency in English, German would be an advantage
Role and Responsibilities
- Planning & Execution of MSAT activities to ensure successful process transfer into the manufacturing plants according to overall project timelines
- Setup and maintenance of GMP process transfer documentation and risk assessments. Deliver process know-how, scientific expertise as well as operational excellence into LBP-production and continuous improvement
- Support trouble shooting, deviation- and change-management. Anticipate, respond and permanently resolve issues that arise during production. Will consult and work with SMEs from other departments
- Lead or contribution to production performance monitoring
- Contribution to the development and implementation of standardized MSAT procedures and processes
- Driving continuous improvements in performing and ensuring alignment to current industry guidance and practices
- Represents MSAT during regulatory inspections and customer audits as SME.
- Works closely with manufacturing department and Quality organization. Ensures a good information exchange and issue escalation throughout all organizational levels and functions. Potential collaboration with Lonza MSAT organization
- Live and contribute to the Bacthera culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside the own area of responsibility.
- Implements a vision as service provider and customer focus in the organization
You will be based in Visp, Switzerland and will report to the Head of MSAT. Are you interested to work for an innovative, dynamic and future oriented start-up company? If you are looking for a new challenging role, were you can bring in your experience and leave your footprint then send us your full application to Ms. Sandra Gamboni, Head of Human Resources; HR@bacthera.com.