Team Lead Drug Substance Manufacturing
Vor 5 Tagen
Bacthera is a 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.
**Create your own future as**:
**Team Lead Drug Substance **Manufacturing** **(f/m/d) 100%**
Functional lead of manufacturing specialists. Manages and supports the operational activities of a GMP Drug Substance production unit with regard to safety, quality and on-time-in full delivery. Is accountable for the performance and results in the Drug Substance area. Member of the Manufacturing Leadership Team
**My main tasks will be **
- Manage a team of manufacturing specialists with full responsibility for all aspects of human resource management such as qualification, development, coaching, hiring and discipline issues
- Responsible for resource and vacation planning of the assigned team members with regard to the fulfilment of all production orders - Ensure a good information exchange from the upper management levels to his/her team and the other way around through regularly team meetings and escalation of production issues
- Implement the Bacthera culture via openness for change and new ideas, customer focus, cooperative teamwork and continuous improvement even outside his/her own area of responsibility
- Be accountable for the execution of all production campaigns in the GMP Drug Substance manufacturing unit with regard to safety, budget, quality and delivery
- Be accountable for cGMP compliance of batches produced in his/her area of responsibility
- Driver of solving production issues in the Drug Substance field according to the common escalation guidelines. Good collaboration with the support functions MSAT, Production Support, QA and the Drug Product production teams with expertise in solution finding and trouble shooting
- Supervise and validate risk analysis and manufacturing work place inspections
- Responsible for the approval of technical change request for the Drug Substance manufacturing unit
- Responsible for setting up the training activities and implement new technology in the DSP operations unit. Definition of demand and requirements and aligning with Training Team
- Representing the operational area in customer meetings, audits and regulatory inspections
- Deputy of the Head of DS Manufacturing
- Working as production expert in Capital investment projects for building and commissioning of the manufacturing units. Main responsible for delivering all input required for the specific set-up, commissioning and qualification of the manufacturing suites and equipment including automation
- Responsible for implementation of the relevant GMP documents for the respective area
- As a member of the Manufacturing Leadership Team responsible for all aspect of general production management such as housekeeping, staff behavior and control of general processes and installations
- Responsible for regular performance control such as weekly report, dashboard, Hoshin Board and other reporting tools incl. definition of appropriate actions for performance enhancing
- Responsible for the approval of technical change request for his/her area of responsibility
- Execute innovation and improvement projects comprising general manufacturing aspects for the production plant
- Ensure a high level of technical and process standardization within the production
**I bring with me**
- MSc or related degree in Chemistry, Chemical Engineering, Biotechnology, Bioengineering or related fields
- + 6 years’ experience in Biotechnical manufacturing or cGMP manufacturing of API/drug substance in the pharmaceutical sector, preferably in biopharma/biotechnology and microbial fermented products
- Experienced in managing a production team and a cGMP facility - Strong leadership skills; very good communication skills in English and interaction with all kinds of interfaces within the organization; strong team orientation
- Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive; solution-oriented
- Proactively seeks to understand internal/external customer and market needs
- Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement
- Establishes and consistently delivers on KPIs and challenging goals for him/herself (and team)
- Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time
- Takes personal accountability for defining and implementing his/her own development and supports others to do same
- Ensures clear and direct 2-way communication within his/her team and other organiza
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