Proclinical Staffing

Senior Manager Downstream Process Development

5 days left

Location
Switzerland
Salary
£116.60 - £117.44 per hour
Posted
29 Apr 2021
Closes
13 May 2021
Ref
37254
Contact
Alex Bero
Discipline
Manufacturing, Process
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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.

#LI-AB1

Apply for Senior Manager Downstream Process Development

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.