Ajankohtaista

CMC Scientist Early Drug Development

17.7.2022 | Avoimet työpaikat

Apply here

To further strengthen our CMC team, we are looking for a motivated CMC Scientist Early Drug Development. The selected candidate will play a key role in the design and selection of new innovative large molecule drug candidates and will support the development of such candidates towards first in human clinical studies. He/she will work in close concert with internal research teams as well as external development parties. The CMC Scientist brings expertise to drive the development of novel drug candidates and helps to overcome development challenges.


Key Accountabilities and Responsibilities:

Supports the early CMC development of drug candidates including:

– Design lead candidates (in collaboration with Discovery);

– Manufacturability assessment of lead candidates;

– Early stage formulation development;

– Early stage productivity assessment;

– Manufacturing process development;

  • Development/selection of appropriate analytical methods including potency assay;
  • Transfers the selected lead candidate to selected third party CDMO;
  • Supports oversight of IND development track at selected CDMO partners by providing CMC development expert input and expert knowledge of the to be developed drug candidate;
  • Technical review of CMC documents (e.g. process development protocols/reports, validation protocols/reports, stability protocols/reports, etc.) and batch manufacturing records with minimal
  • guidance and able to draw appropriate conclusions;
  • Proactively identify and track project critical path items ‐ identify risks, formulate and monitor
  • corrective actions;
  • As a member of the CMC team actively contribute to technical and strategic CMC discussions.

Desired skills & experience:

  • PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical / biotechnology sciences;
  • Strong technical expertise in the field of biological drug substance and drug product manufacturing, product characterization;
  • Good understanding of antibody engineering and design of complex proteins;
  • Able to analyze and synthetize relevant literature and to transfer knowledge to a broader audience;
  • Good knowledge of ICH and GMP regulations;
  • Ability to work at the interface between research and development;
  • Team player with a can do mentality;
  • Able to operate in a dynamic surrounding of a fast‐growing biotech company with challenging timelines and changing priorities;
  • Fluent in English, written and spoken.

Offer:

  • 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