Life Science Recruiter, specialised in Scientific
Our client is looking for an Upstream Process Development Manager, on a permanent basis, to join his team. The person should ideally have experience in upstream cell culture, manufacturing, and science activities as well as late-stage development (close to commercial or commercial products).
Key Responsibilities
* Oversee and guide outsourced (CDMO) upstream process and cell bank related activities around the technical development, approval and life cycle management of Biosimilar drug substance production; including process tech transfer, GMP manufacturing of drug substance, IND application authoring/review of CMC sections, process characterization and validation, and authoring/review of CMC sections for BLA/MAA, deviation and change control support as subject matter expert.
* Provide scientific and technical oversight for the upstream process development activities at drug substance manufacturing CDMO.
* Define technical development that follows the principles of Quality by Design in line with relevant regulatory requirements and guidelines; specify activities required for preparation of Statement of Work (SOW); review the activities, timelines, and costs at drug substance manufacturing CDMO.
* Assume a leading role in the planning and execution of USP technology transfer activities for handover and scale up of projects to external GMP manufacturing sites or for tech transfer of commercial products; design and guide process characterization studies and process validation support activities.
* Review and approve external technical development protocols/reports; prepare and update Annual Process Development History Report.
Requirements
* Minimum Master's or Bachelor's degree in life sciences or engineering.
* Minimum 10 years relevant experience in the Biotech Industry with a demonstrated track record in Upstream processing for biologics, preferably with mammalian cell culture and monoclonal antibody experience; previous experience working with biosimilars would also be an advantage.
* Strong technical expertise across the Upstream development spectrum including process development, scale up and tech transfer, large scale manufacturing, process characterization, process validation and life cycle management of commercial products.
* Technical leadership and influencing skills to drive teams to deliver.
* Fluency in English; French would be an asset.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Management and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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