Senior Manufacturing Scientist (Drug Substance) (f/m/d) 100% – Hørsholm, DK
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 Hørsholm we are seeking a motivated, open minded and experienced person as:
Senior Manufacturing Scientist (Drug Substance) (f/m/d) 100%
Work within our Drug Substance manufacturing team to support the Tech transfer of production processes into our GMP facility. Drives facility fit and continuous improvement in manufacturing of Live Biotherapeutic Products (LBP) for our customers.
- Min. a master’s or PhD degree in a relevant life science or engineering field (5-year education) or similar.
- Min. 3 years’ experience with tech transfer or MSAT role in a manufacturing department within a life science or Biopharmaceutical sector.
- Demonstrated solid experience in fermentation technology and processes at production scale, preferably microbial processes.
- Knowledge of concentration and drying technologies in therapeutic applications.
- Knowledge of cleaning and/or process validation would be beneficial.
- Proven track record of experience in working in a cGMP production environment.
- Experienced in and comfortable with inspections and audits.
- Excellent collaboration and communication skills, proactive, solution-oriented team-player.
- Proven experience in working with Lean tools.
Roles and Responsibilities:
- Represents the Manufacturing team in Customer programs.
- Partners with the Process Development department and represents manufacturing as the receiving unit for new manufacturing processes developed, ensuring facility and cGMP fit as process is being developed.
- Ensures facility fit during the tech transfer from Process development to DS Manufacturing.
- Manages planning and coordination of tech transfer activities in Manufacturing to meet the production plan.
- Collaborates closely with the QA and QC Departments.
- Will function as the Process SME with Manufacturing.
- Drives GMP readiness for new and existing manufacturing processes.
Driving production activities
- Supports Manufacturing during the execution of DS processes, providing technical and scientific support throughout campaigns as required.
- Coordinates major 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.
- Drives continuous improvement by coordinating lessons learnt after batches, sharing feedback and learnings with Development departments, and ensuring improvements are implemented
- Provides the input to Business Development and Project Management when scoping new customer projects within the area of production capabilities and performing ‘initial’ facility fit evaluation as part of customer prospect review.
Are you interested to work for an innovative, dynamic, and future oriented start-up CDMO company? Are you looking for a new challenging role where you can create things and leave your footprint? If you can answer those questions with YES, then send us your cover letter and CV to Ms. Sandra Gamboni, Head of Human Resources; email@example.com. We are looking forward to welcoming you in our new production site in Hørsholm.