Seuss Consulting

Scientist Process Development CMC

14 Feb 2021
16 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Scientist Process Development CMC
Our client is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Purpose of the role
The Scientist Process Development CMC retains a high level of ownership for multiple pre-clinical and clinical-stage programs by being responsible for all program-specific process development; process characterization; inter-departmental communications; supporting regulatory filings; and leading technology transfer to the company’s manufacturing site in Lexington, the United States.

Place in the Organization
The Process Development (PD) department in Amsterdam is a part of Global Product and Research Development. The PD-CMC group, to which this position applies, is a sub-group of the PD department and consists of several scientists and (senior) technicians lead by a Senior Scientist. Within the group, each scientist represents the PD department in cross-functional CMC teams aiming to industrialize ground-breaking AAV-based gene therapy products.

Key result areas (major duties, accountabilities, and responsibilities)
  • Owns / manages / coordinates activities on early stage (preclinical to clinical) process development and preclinical manufacturing as a part of (IND enabling) CMC programs. Leads process transfer for GMP manufacturing
  • Performs line managerial duties for multiple (senior) technicians
  • Develops, characterizes, and improves platform processes
  • Designs / outlines (masterminds) experimental plans to meet assigned objectives. Writes / reviews / approves process descriptions, experimental protocols and non-GMP batch production records
  • Trains, motivates, and collaborates with a team of (senior) technicians. Coordinates / supervises the activities in the lab and when necessary performs experiments him/herself
  • Analyses / reviews experimental results / data, writes / reviews reports (g. experimental report, overall development report, production (campaign) report, investigation report) and sections of regulatory submission documents
  • Represents PD department in the CMC team and acts as PD’s point-of-contact for other departments on the assigned CMC program(s). Maintains a robust communication with all relevant functions that have an impact on or are impacted by the PD Amsterdam department, especially with Manufacturing and PD Lexington departments
  • Presents results in conferences, writes journal articles and scientific content of patent applications
Qualifications & Skills
  • Holds a PhD in Bioprocess Engineering, Biotechnology, or similar field. Alternatively, in certain circumstances, holds 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
Core competencies
  • High level of ownership of the assigned programs
  • Team player with an attitude to motivate teams and high level of interpersonal skills
  • Possesses a strong scientific mindset and analytical skills
  • Flexible to act in a highly dynamic and demanding environment
  • Strong communicator who can easily explain complex issues verbally and in writing; and understands what, when and whom to communicate to.

Please contact Ian Wood, Senior Recruitment Consultant. +31 (0)6 26 65 71 71.

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