Head of Production
A successful, leading Biologics CDMO are looking for a Head of Production to join one of their state of the art sites in Heidelberg, Germany. The services they provide include the development of cell lines, production processes, as well as non-GMP and GMP manufacturing of biopharmaceutical drug substances and drug product. They have gone from strength to strength in the last year and are in the process of up-scaling a brand new GMP facility. This company can offer a great working environment, including flexible working hours, a flat hierarchy, short decision making paths and a collegial working environment.
Responsibilities:
- Management of the biopharmaceutical production site as well as overall responsibility for commercial manufacturing and infrastructure expansion planning
- Responsibility of the production budget
- Creation and approval of SOP's, Specifications, Protocols, GMP and IMPD
- Development of fermentation processes, process optimisation and scale up of production processes as well as development of purification processes (DSP)
- Contributing to quality assurance measures, deviations, risk assessment and change control procedures
- Resource and personnel planning
Requirements:
- PHD or Masters in Biochemistry, Biotechnology, Biology, Pharmacy or related field
- 5+ years experience managing a biopharmaceutical production, in the field of CDMO business, from clinical trial to commercial supply
- Experience in the expansion of production facilities, capital expenditure financial planning and implementation cycles
- Experience leading a team and working in interdisciplinary teams
- Fluent English and German
If you are interested in this role, please apply with your CV.