Senior Manager Downstream Process Development

Hobson Prior are working with a world-wide healthcare organisation whose products and services are used to help care for patients who are critically ill. Our client is looking for a Senior Manager Downstream Process Development to join them on a permanent basis.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Collaborate and support to the analytics team to outline the technical corridor for analytical similarity to be achieved when developing biosimilar products.
• You will supply 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.
• You will be leading the planning and execution of DSP tech transfer activities for handover and scale up of projects to external GMP manufacturing sites.
• You will 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.
• To manage and guide outsourced downstream activities around the technical development of a Biosimilar; including, downstream process development and manufacture of drug substance, clinical trial supply, process characterization and validation, Cost of Goods optimisation, and submission of CMC documents.
• To review and approve external protocols / reports and other documents.
• Provide technical and scientific oversight of licensed downstream processes to confirm consistency of supply.
• You will outline technical development that follows the principles of Quality by Design and specify activities, timelines, milestones and costs in collaboration with Global Manufacturing and Supply; design and guide process characterization and process validation support activities.
• 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.
• You will represent Downstream Process Development at cross functional meetings.

Key Skills:

• Technical leadership and influencing skills to drive teams to deliver.
• Strong analytical skills and ability to critically evaluate scientific data obtained at different stages of development.
• Ability to work on multiple projects concurrently and flexibility to switch between projects if necessary.

Requirements:

• Educated at a masters in Science or Engineering, or BSc with added experience.
• Fluency in English essential, French and/or German would be an asset.
• At least 7 years' experience in Biotech/Biosimilars Industry with demonstrated track record in Downstream processing for biologics.
• Strong technical expertise across the Downstream development spectrum including process development, scale up, tech transfer, large scale manufacturing and process characterization.
• Previous experience in evaluation and implementation of new technologies are desirable but not essential.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.