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Sr. Scientist CMC

Job description

For a clinical‐stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics, we are currently searching for a Senior Scientist CMC. The Senior Scientist CMC will be responsible for authoring and reviewing of quality submission packages for large molecule therapeutic drug candidates throughout their clinical development towards marketing approval. In this role you will be able to weigh into CMC development strategies.

Contributes to the CMC development of pre‐clinical and clinical stage development programs in close collaboration with the CMC team members by:

  • Authoring and preparing IND, IMPD, scientific briefing documents, Investigator Brochures and regulatory agency response documents for therapeutic compounds in development in close collaboration with external and internal stakeholders;
  • Authoring and preparing and BLA, Japan‐CTD, MAA quality documentation packages (module 2 and 3);
  • Ensuring submission packages are complete and compliant with applicable regulatory and country specific requirements;
  • Coordinating activities with external partners ensuring that deliverables are executed with the right priorities and to the required standards;
  • Authoring technical source protocols and reports related to drug development activities;
  • Providing strategic input into CMC development activities;
  • Tracking execution of regulatory commitments.
Skills and personality
  • Master’s degree or PhD in biotechnology, pharmaceutical sciences or bio‐engineering, with relevant expertise in CMC development and CMC regulatory dossier development (IND/IMPD/BLA/MAA);
  • Science oriented, experience with large molecules is a plus;
  • Excellent writing skills coupled with comprehensive knowledge of pharmacopoeial requirements, ICH guidelines, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements;
  • Team player; able to build effective relationships with internal and external stakeholders;
  • Well organized and able to handle multiple assignments in parallel;
  • Proficiency with MS‐Word and preferably with document management systems;
  • Eye for detail and quality conscious attitude;
  • Well organized;
  • Excellent interpersonal and communication skills;
  • Fluent in English – our working language;
Contract

Executive search

Experience

minimum 4 years

Education

Bachelor and/or Master in Pharmaceutical and Biological techniques

Languages

English

Sector

Pharmaceutical industry

Region

Gent

Job type

Full-time

 
 

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