Drug Product Process Development Engineer

Vor 2 Tagen

CH Lausanne AC Immune SA Vollzeit

Drug Product Process Development Engineer
Description
Function Drug Product Process Development Engineer
Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne
hr@acimmune.com
Percentage 100 %
Reporting Line DP Manufacturing Science and Technology Group Leader
Overview AC Immune is a clinical-stage Swiss Biotech Company focused on the development
of innovative therapeutics and diagnostics for Alzheimer’s and other
neurodegenerative diseases.
Job description The Drug Product Process Development Engineer will assist the technology transfer,
process optimization and scale-up for all drug product manufacturing development
activities to contract manufacturing organizations. The candidate will also assist build-
up of in-house vaccine manufacturing capabilities to facilitate industrialization of
newly developed processes.
Key responsibilities

  • Assist technology transfer and scale-up of all manufacturing activities until GMP
    production. Carry out risk analyses and PFMEA on manufacturing processes
  • Liaise internally within AC Immune and externally with CMOs to fill identified
    gaps and/or mitigate risks to ensure successful technology transfers
  • Plan and monitor the engineering runs. Carry out process performance analysis
  • Assist initiation of GMP manufacturing activities
  • Ensure mirroring of manufacturing processes between AC Immune and CMOs
  • Identify pilot-scale equipment suitable for in-house manufacturing activities,
    contact external vendors, carry out RFI/RFP process to assess
    equipment/system suitability to build these capabilities
  • Contribute to maintenance of inventory of materials and consumables used by
    the MFG team
  • Support budget preparation related to in-house operations

Qualifications Qualifications:

  • Bachelor or MSc in process engineering, pharmaceutical engineering, systems
    engineering, mechanical engineering or similar
  • Has at least 5 years of industrial experience, with expertise in multiple types of
    industrial equipment and processes (mixers, filtration, purification devices).
  • Has proven expertise in failure mode analysis and process performance
    analysis.
  • Has demonstrated ability to solve complex engineering challenges in highly
    dynamic environments with internal and external stakeholders
  • Has demonstrated ability to analyze data and generate reports

Personal features include:

  • Strong technical acumen
  • Ability to integrate and learn fast
  • Strong interpersonal skills for efficient collaboration with all colleagues
  • Fluency in spoken and written English

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