We combine best-in-class capabilities from our two founding partners, including extensive know-how in developing, upscaling and manufacturing live bacteria, strong capabilities in pharma contract manufacturing, and outstanding formulation and drug delivery technologies, including the unique enTRinsic™ capsules.
Bacthera operates from its headquarters in Basel (CH) and has development and production facilities in Denmark and Switzerland. Bacthera is the first contract development and manufacturing organisation (CDMO) to provide a full supply chain that offers manufacturing of live bacteria for therapeutic use for biotech and pharma customers.
For our site in Basel we are seeking a motivated, open minded and experienced person as:
Work within DP Operations team to support development, tech transfer (TT) and manufacturing of Live Biotherapeutic Products (LBP) for our customers. Drives facility fit, process design and continuous improvement in manufacturing.
Your Profile:
- A Master (minimum) or PhD degree in a relevant life science or engineering field or similar
- Min. 5 years’ experience with oral DP process and/or formulation development, tech transfer or MSAT role in pharma manufacturing (life science / bio-pharma preferred)
- Demonstrated experience in oral solid DP formulation and process design
- Knowledge in process validation would be beneficial
- Preference: Experience in working in a cGMP production environment
- Preference : Proven experience in working with Lean tools
- Experienced in and comfortable with Quality inspections and audits
- Excellent collaboration and communication skills
- Proactive, solution-oriented team-player
Role and Responsibilities
Process Development and Technology transfer
- Lead and SME in the design of process and formulation development programs for customer’s oral LBP
- Drive process and formulation development activities together with technicians
- Lead the TT and facility fit of developed programs into our cGMP manufacturing facility, working with the production teams
Implementing processes
- Will function as the Process SME with Production
- Drives GMP readiness for new and existing manufacturing processes, including:
Driving production activities
- Supports Production during the execution of DP manufacturing, providing technical and scientific support throughout campaigns as required
- Coordinates process investigations in response to major or critical deviations observed during manufacturing. Will consult and bring on board SMEs from other departments
- Supports in driving a culture of Operational Excellence, ensuring Bacthera delivers on KPIs associated with Right First Time and On Time Delivery
Validation
- Key contributor to Process Validation activities within Bacthera for a product and delivering Process Validation activities in the DP development and manufacturing facilities
Commercial support
- Represents DP Operations team in customer programs
- Provides the input to Business Development and Project Management when scoping new customer projects within the area of process and formulation development, production capabilities and performing ‘initial’ facility fit evaluation as part of prospect review
Are you interested to work for an innovative, dynamic and future oriented start-up company? Are you looking for a new challenging role where you can create things and leave your footprint?