Scientist Process Development CMC job in Amsterdam, Netherlands

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Job type: Permanent

Discipline: Biological Sciences

Location: Netherlands

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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.

Job Responsibilities

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