Experienced Scientist within Biopharma Manufacturing Development - Denmark
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Experienced Scientist within Biopharma Manufacturing Development
- Become part of the successful journey in our company.
- We are facing an exciting development with many new vaccines in the pipeline for cancer and infectious diseases.
- To support our projects s well as the existing vaccine production, we are expanding the Process Development Department and are looking for an experienced scientist for the Manufacturing Development Team.
- In the Manufacturing Development team we are responsible for Tech Transfer of manufacturing processes from both our Process Development laboratories and CMOs.
- If you like to take overall responsibility for meeting projects milestones and ensuring high scientific level of quality documentation for transfer and establishment of manufacturing processes for both CTM and commercial vaccine products, this might be the job for you.
- In this position you will work closely together with colleagues from our Process Development laboratories, Production, QC laboratories, R&D, and Regulatory Affairs in projects teams where you – as scientific lead on the tech transfer packages - will help to ensure that the overall data package for the project fulfils the needs for manufacturing, release and regulatory submission of the specific products.
- For some of the projects, you will also collaborate with our external partners.
- You will work closely together with 6 colleagues in the team and report to the Manager for the Manufacturing Development Team.
- Tech Transfer
- Compile and evaluate all relevant development and manufacturing data to support transfer of the process, including support to design of Process Development studies (e.g. DoE)
- Work with the statisticians for analyses of the development data
- Write protocols and reports for technical/engineering runs in Production
- Support Production with scientific input and review of protocols and reports for Process Performance Qualification and Process Validation
- Write or give input to control strategies including assessment of critical process parameters for manufacturing processes
- Deliver required documentation for regulatory submissions on specific projects
- Participate in group to ensure establishment and update of relevant SOPs for tech transfer activities
- Comparability and Characterization
- Participate in update of SOP for comparability
- Write protocols and reports for product comparability and characterization
- General scientific support to e.g. Product Specifications and justifications, Rationales and Risk Assessments, Development Stability (protocols, reports, shelf life extensions), Formal Investigations etc.
- Master in Biochemistry, Chemical Eng., Pharmacy or similar
- Ph.D. is an advantage
- More than 5 year experience from similar position within biomanufacturing with responsibility for tech transfer, manufacturing development, manufacturing support, CMC or similar
- Previous experience from working in project groups
- Fluency in spoken and written English
- As a person you like to take responsibility – also outside own area - and you show drive and influence in the project groups you work in.
- You are an extrovert person who thrives by sparring and collaboration with your close colleagues in the team.
- We offer a very exciting position in a successful Danish, but highly international, company with a unique technology and manufacturing process within vaccine production.
- You will be working in a non-formal culture, where everybody is working in the same direction. There is room for ideas and a very short way to action from the good ideas.