Proclinical Staffing

Senior Manager Downstream Process Development

5 days left

£116.60 - £117.44 per hour
29 Apr 2021
13 May 2021
Alex Bero
Manufacturing, Process
Full Time
Contract Type
Experience Level
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 BiosimilarAssume a leading role in the planning and execution of DSP tech transfer activities for handover and scale up of projects to external GMP manufacturing sitesReview and approve external protocols / reports and other documentsDefine technical development that follows the principles of Quality by Design (QbD) and specify activities, timelines, milestones and costs in collaboration with Global Manufacturing and SupplyProvide support to the analytics team to define the technical corridor for analytical similarity to be achieved when developing biosimilar productsDrive 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 campaignsProvide 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 TeamProvide technical and scientific oversight of licensed downstream processes to ensure consistency of supplyPrepare and review the CMC section of the regulatory dossierServe 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 experienceFluency in English essential, French and/or German would be an assetMinimum 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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