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Senior Manager Downstream Process Development
- Permanent
- Bioprocessing
- Switzerland
This vacancy has now expired. Please see similar roles below...
An exciting opportunity has arisen for a Senior Manager to oversee the Downstream Process Development. You will guide outsourced downstream activities around the technical development of a biosimilar. This role is based in Switzerland and is a fantastic opportunity to join a global company.
Job Responsibilities
- Oversee and guide outsourced (CDO, CMO) downstream activities around the technical development of a Biosimilar
- Assume a leading role in the planning and execution of DSP tech transfer activities for handover and scale up of projects to external GMP manufacturing sites
- Review and approve external protocols / reports and other documents
- Define technical development that follows the principles of Quality by Design (QbD) and specify activities, timelines, milestones and costs in collaboration with Global Manufacturing and Supply
- Provide support to the analytics team to define the technical corridor for analytical similarity to be achieved when developing biosimilar products
- Drive issue resolution for Downstream process in order to achieve analytical similarity within the pre-defined analytical similarity corridor; drive and support downstream troubleshooting and root-cause investigation activities at the CMO during development, GMP, PPQ and commercial campaigns
- Provide scientific and technical guidance for the downstream process development activities for the in-house development labs and to the Biosimilars Development Teams and the Biosimilar Leadership Team
- Provide technical and scientific oversight of licensed downstream processes to ensure consistency of supply
- Prepare and review the CMC section of the regulatory dossier
- Serve as the technical operational downstream expert for regulatory consultations/interactions; including briefing book and dossier creation and question response
- Represent Downstream Process Development at cross functional meetings
Skills and Requirements
- Masters in Science or Engineering, or BSc with added experience
- Fluency in English essential, French and/or German would be an asset
- Minimum 7 years' experience in Biotech/Biosimilars Industry with demonstrated track record in Downstream processing for biologics (specifically mammalian cell culture downstream)
- Strong technical expertise across the Downstream development spectrum including process development, scale up, tech transfer, large scale manufacturing and process characterisation
- Experience in evaluation and implementation of new technologies are desirable but not essential
To Apply
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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