Senior Manager Upstream Process Development page is loaded
Senior Manager Upstream Process Development
Apply locations Eysins Graz Bad Homburg (EK1) time type Full time posted on Posted 30+ Days Ago job requisition id R-10002712
Job Summary
Main Tasks:
* 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 CDMOs
* Define technical development that follow 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 CDMOs
* 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
* Drive and support upstream troubleshooting and root-cause investigation activities at the CDMO during Technology Transfer, GMP Manufacturing, PPQ and commercial campaigns of approved products
* Review and approve external technical development protocols / reports; Prepare and update Annual Process Development History Reports
* Prepare, author and review the relevant CMC sections of regulatory dossiers
* Serve as the technical upstream subject matter expert for regulatory consultations/interactions, including briefing book and dossier preparation and question-response phase with authorities
* Represent Upstream Team at cross functional internal and external meetings
Qualification Profile:
EDUCATION & LANGUAGES
* Minimum Masters or Bachelors degree in life sciences or engineering
* Fluency in English; French would be an asset
PROFESSIONAL SKILLS & EXPERIENCE
* Minimum 10 years relevant experience in the Biotech Industry with demonstrated track record in Upstream processing for biologics, preferably with mammalian cell culture and monoclonal antibody experience; previous experience working with biosimilars would be also 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
JOB SPECIFIC SKILLS & COMPETENCIES
* Technical leadership and influencing skills to drive teams to deliver
* Collaborative, drives engagement and ensures accountability
* 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
* Strategic thinking and cultivates innovation
* Willingness to travel up to 20-30% of the time based on business needs principally to manufacturing sites and to I&D center located in Switzerland
* Ability to work in a matrix organization
* Note: No direct reports for this position
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Fresenius Kabi ( www.fresenius-kabi.com) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients.
With more than 40,000 employees working in 60 countries, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients - and to find answers to the challenges they face. We call this purpose committed to life.
We are proud to be part of the Fresenius Group with its more than 190,000 employees worldwide. Everyday, we use our dedication, expertise, and passion to help advance healthcare opportunities and make a difference in people’s lives everywhere. Follow us on Linkedin to learn more.
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