Proclinical are working on an amazing job opportunity for an ADC Chemistry MS&T Manager / Senior Manager at a multinational pharmaceutical company based in Switzerland. With over 5000 products, found in virtually every area of human activity this company is associated with some of the leading brands around the world.
- Supporting manufacturing activities for late stage clinical and commercial recombinant protein manufacturing at external partner sites
- Providing technical and scientific leadership as subject matter expert (SME) relating to technology transfers, manufacturing processes, complex deviations, technical troubleshooting, process monitoring, change control and process optimisation
- Partnering with other functions to apply e.g. modelling tools ensuring that scale-down/scale-up and characterisation of manufacturing processes are robust and scientifically sound leading to a predictable and highly consistent performance and a well characterised process
- Providing guidance for root causes investigations of process related deviations in a timely, comprehensive and conclusive manner.
- Interfacing with Development and manufacturing sites for know- how transfers and process data analysis & mapping.
Skills and Requirements:
- Bachelor's degree in biotechnology, bioengineering or another relevant life-science discipline with industrial experience in the relevant process technologies, technology transfers, validation, GMP manufacturing and/or process optimisation
- Strong scientific and technical experience within relevant biologics development and/or manufacturing technologies.
- Experience with equipment utilised in commercial cGMP manufacturing facilities
- Good knowledge of structured methodologies for process design, scale-up/-down models, process control strategies, validation and continuous process verification as applied to biologics manufacturing
- The ability to work in a matrix-based organisation relative to changing priorities and urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross- site teams
- A good understanding of statistical analysis and continuous process verification is desirable
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Valaince Penteng on +44 2038 4606 43 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.