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CMC Sr. Scientist Drug Substance

Job description

For a commercial biopharmaceutical company, we are looking for a CMC Sr. Scientist Drug Substance to further strengthen their CMC DS Science team.    The company creates and develops a pipeline of differentiated antibody therapeutics. He/she will be leading technology transfer and scale-up of a drug substance (DS) manufacturing process, as well as process characterization and process qualification activities for a novel therapeutic antibody. This is a unique opportunity to work in the heart of a development and commercial organization in close collaboration with different CMC disciplines.


  • Lead, in collaboration with internal and external stakeholders, the technology transfer of drug substance processes (upstream and downstream) to external manufacturing sites.  

In this role you will be:

  • Responsible for delivering the project in close collaboration with all relevant stakeholders, and be responsible for effective communication on progress,
  • Responsible for review of tech transfer and manufacturing documentation such as risk assessments, facility fit analysis, gap analyses, process descriptions, sample plans and batch records,
  • Expected to drive process optimizations from obtained data learnings;
  • Lead process characterization activities in context of a potential commercial process design and validation;
  • Review CMC DS dossier sections to support timely submission of clinical trial applications and (s)BLA/MAA/J-MAA filings;
  • As a member of the CMC team actively contribute to technical and strategic CMC discussions;
  • Proactively identify and track project critical path items ‐ identify risks, formulate and monitor corrective actions and communicate risk to CMC leadership;
  • Work in close collaboration with quality assurance to ensure activities are performed in line with the required quality standards and to ensure inspection readiness;
  • Provides input to budget forecast cycles.


  • PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical / biotechnology sciences
  • Strong technical expertise in the field of biological drug substance manufacturing, tech transfer and scale up, process validation, or commercial manufacturing
  • Expected experience: >5y within relevant industry
  • Relevant experience in project management and outsourced activities
  • Fluent in English, written and spoken
  • In depth knowledge of ICH and GMP regulations;
  • Works independently within the scope of his assigned field and supports others;
  • Keep abreast with relevant scientific and/or technical developments. Searches literature and other sources independently and applies knowledge;
  • Excellent organizational and coordination skills;
  • Ability to go into detail whilst keeping the view on the overall project goal;
  • Strong technical expertise combined with good project management skills and ability to communicate effectively with internal and external stakeholders;
  • Flexible attitude, capable to balance multiple priorities;
  • Quality conscious attitude;
  • Experience and knowledge in the preparation of regulatory submissions;
  • Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines;


  • A competitive salary package with extensive benefits
  • Front seat in the development of therapeutic antibodies
  • A work environment in a human-sized, dynamic and rapidly growing biotech company


Executive search


Minimum 5 years


Higher Scientific Degree




Pharmaceutical industry



Job Type


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