POS 3935
Status 10

GMP API Expert

Description: For one of our German Pharma clients we are seeking freelance support as: GMP API Expert (M/F/D)
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  • Support the CMC Team by route scouting and PRD process optimization
  • Support all GMP relevant outsourcing CMC activities for all small molecule development projects
  • Follow up validation activities and select of 2nd Manufacturer
  • Preparation for GMP campaign and process transfer to scale synthesis
  • Review study plans and evaluate/ review PAR studies
  • Document and review dossier relevant reports incl. analytical validation protocols and master batch records
  • SOP management (update and write)
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  • Start: asap // Duration: 12 months + // Capacity: 2-3 days/week mainly remote
  • PhD in Chemistry or similar
  • Profund industrial experience within GMP manufacturing and process development
  • Profunde knowledge in in protein/monoclonal antibodies/bispecifics formulation for both early and late phase development
  • Experience in process development related to drug products manufacturing (lyophilization) and drug substance
  • Significant experience in early stage project API synthesis and scale up
  • Senior experiences DS synthesis
  • Experience in Leading teams up to 5 people as well as lager project teams
  • Experience with regulatory submission US/EU and technology transfer
  • Business fluency in English, German is a plus
Other remarks: WANTED: GMP API Expert (M/F/D). Please contact +49 89 18 90 998 13 or Skills: CRO Experience, EMA (European Medicines Agency), English, FDA (USA: Food and Drug Administration), German, GMP (Good Manufacturing Practice), Pharma, QA (Quality Assurance), QC (Quality Control)
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Let’s go!
Begin date: asap
Job Duration: 12 months
Location: remote
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