Job Offers

 


Consultant CMC

Tasks & responsibilities

 

The Consultant CMC is the quality expert in the Granzer team, providing knowledge on broad range of drug substances (from small molecules to synthetic oligonucleotides to biologicals) and drug products (from solid orals to sterile solutions to nanoparticulate formulations). This function will cover all quality related topics from pre-clinical development to approved commercial products, including the following:

 

  • Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team.
  • Ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable approval of regulatory submissions.
  • Preparation of quality sections for MAA and BLA/NDA as well as for IMPD and IND.
  • Perform gap analyses of client-provided packages. Identify critical CMC development issues and develop strategies for their resolution.
  • Support due diligence processes.
  • Prepare briefing packages for agency meetings (e.g. scientific advice, oral explanation, EoP2) and conduct such meetings together with the client.
  • Management of operational and strategical aspects with CDMOs.
  • Coordination of filing activities within the cross-functional Granzer team and with contributing parties.
  • Continued observance of regulatory guidance and regulations.

 

 

Requirements

 

  • Ph.D. or master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable.
  • At least five years in a scientific/technical CMC development or regulatory affairs function.
  • Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
  • Excellent communication and negotiation skills in English. German language skills are a plus.
  • Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial.
  • Highly motivated team player with strong interpersonal abilities.
  • Sound knowledge of Microsoft Office applications.
  • Willingness to travel moderately (Meetings with clients, agencies or CMOs).

 

If you are interested in working in an innovative and team-oriented environment, please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz

 

Senior Consultant - Preclinical

Tasks & responsibilities

 

This function covers all non-clinical topics from early development, i.e. concerning transition from research to development including nonclinical requirements for FIM studies, selection of and collaboration with CROs for conduct of non-clinical studies, and non-clinical requirements including dossier preparation for MAA or BLA/NDA filing.

In particular:

 

  • Provide advice to clients on non-clinical aspects of drug development and regulatory requirements in collaboration with CMC and clinical experts in the Granzer team
  • Ensure that the content of non-clinical documents is appropriate, meets regulatory expectations and enables approval of regulatory submissions
  • Prepare non-clinical development plan
  • Perform gap analyses of development packages provided by clients
  • Support due diligence processes
  • Support clients in meetings with regulatory agencies and moderate such meetings
  • Prepare IBs for CTA
  • Prepare responses to deficiency letters in collaboration with CMC and clinical experts in the Granzer team
  • Prepare briefing packages for meetings with regulatory agencies (national regulatory agencies, EMA and FDA)
  • Continuously check scientific and regulatory guidance

 

Requirements

 

  • Degree in medicine/veterinary medicine, pharmacy or biology/biochemistry/chemistry.
  • More than ten years of experience in the pharmaceutical industry in a position in research, non-clinical development or regulatory affairs
  • Knowledge of ┬áin non-clinical and regulatory requirements for all stages of drug development
  • Experience in the preparation of regulatory documentation related to CTA, MAA, IND, BLA/NDA
  • Excellent communication and negotiation skills in English
  • Highly motivated team player with strong interpersonal abilities
  • Sound knowledge of Microsoft Office applications
  • Willingness to travel moderately (meetings with clients, regulatory agencies or CROs