Scientist Process Development CMC
An amazing job opportunity has arisen in Amsterdam for a Scientist Process Development CMC. This is the perfect chance to bring your experience and expertise to a leading biopharmaceutical organisation.
- Coordinates activities on early stage (preclinical to clinical) process development and preclinical manufacturing as a part of CMC programs. Leads process transfer for GMP manufacturing
- Performs line managerial duties for multiple (senior) technicians
- Develops, characterizes, and improves platform processes
- Trains, motivates and collaborates with a team of (senior) technicians. Supervises the activities in the lab and when necessary performs experiments themselves
- Analyzes experimental data, reviews reports and sections of regulatory submission documents
- Represents the department in the CMC team and acts as point-of-contact for other departments on the assigned CMC program
- Maintains a robust communication with all relevant functions that have an impact on or are impacted by the Amsterdam department.
Skills and Requirements
- Holds a PhD in Bioprocess Engineering, Biotechnology or similar field or MSc with 6+ years of relevant work experience to match a PhD level
- Possesses minimum 2 years of post-PhD (or 6 years of post-MSc) work experience in process development or GMP manufacturing support or similar functions
- Experienced in multiple areas from the followings: Process development, cell culture (fermentation) technologies, upstream processing, protein purification technologies, downstream processing, industrial process design, technology transfer, adeno associated virus (AAV), bio-analytics, scale up / down, process validation, GMP manufacturing, pharmaceutical quality management systems, common technical documents (CTD)
- Hands-on experience on complex biologics, e.g. gene therapy, viral vaccines, therapeutic proteins
- Excellent scientific writing skill demonstrated by publications and reports
- Fluent in English
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.