Scientist Process Development CMC

Highly Competitive
  1. Permanent
  2. Biological Sciences
  3. Netherlands
Amsterdam, Netherlands
Posting date: 15 Jul 2020
This vacancy has now expired

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

To Apply

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A full job description is available on request.