AiCuris Anti-infective Cures AG

Drug Substance Manager

AiCuris Anti-infective Cures AG

full-time

Posted on:

Location Type: Hybrid

Location: Wuppertal • 🇩🇪 Germany

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Job Level

Mid-LevelSenior

About the role

  • CMO/ CDMO/ CRO management for API manufacturing of small molecules and Tides (mainly Oligonucleotides) for clinical study supply and early commercial phases
  • Management of all aspects of technical drug substance development (eg, analytics, solid state assessment, impurity profiling, route finding)
  • Close interaction with QA/QC to manage CAPAs, change controls, quality incidents, writing of SOPs and participating in audits as technical expert
  • Supply chain management of APIs, Regulatory Starting Materials, and other critical reagents
  • Support of selection and evaluation of suitable CMOs/ CDMOs/ CROs for GMP manufacture and testing
  • Cost of good assessment, support of commercial phase preparation, and post-approval activities
  • Support of regulatory fillings in US and EU (eg, CTD module 3) and review of quality documentation relevant for manufacturing and testing (eg, MBR, validation protocols)

Requirements

  • PhD (or equivalent) in Chemistry or Pharmaceutical Technology or similar
  • At least 5 years of post-graduate professional experience in the pharmaceutical / biotech industry
  • Profound experience in CMC development for early- and late-phase programs, specifically with drug substance related activities
  • Exposure to the principles of QbD (Quality by Design) and DoE (Design of Experiment)
  • Experience in CMO/CDMO/CRO management and collaboration with external partners
  • Experience with supporting regulatory filings in US and EU
  • Sound expertise in GMP-compliant drug substance manufacturing and testing, including validation and transfer
  • Ability to efficiently evaluate, prioritize and handle multiple project tasks
  • Highly motivated and ability to work independently as well as in the team
  • Excellent organizational and communication skills
  • Business fluent in English; German skills would be beneficial.
Benefits
  • Employer-funded pension
  • Attractive benefits package

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
API manufacturingdrug substance developmentanalyticssolid state assessmentimpurity profilingroute findingGMP-compliant manufacturingvalidation protocolsregulatory filingsQbD
Soft skills
project managementorganizational skillscommunication skillsteamworkindependencemotivationprioritizationevaluation skills
Certifications
PhD in ChemistryPhD in Pharmaceutical Technology