Quality Control Lead

Vor 3 Tagen

Lausanne, Waadt, Schweiz AC Immune SA Vollzeit

Quality Control Lead – NEW

Description
Function Quality Control Lead
Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne

Percentage 100 %
Reporting Line Analytical Development & Quality Control (ADQC) 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.

AC Immune is seeking a highly qualified Quality Control Lead to support its CMC
product development programs. The candidate must possess a strong background in
Analytical Chemistry or equivalent and must have extensive Quality Control
experience, preferably in the (bio)pharmaceutical industry and in the interface with
Quality Assurance and Regulatory Affairs functions.

Job description
•Lead and manage analytical method transfer, qualification and/or validation
activities to/at external partner(s) or Contract Research Organizations (CROs),
including revision and approval of required documentation, for Drug Products,
APIs and raw materials

  • Ensure that Release, Characterization and Stability testing by partners or
    Contract manufacturing Organizations (CMOs) and CROs is performed in
    compliance with cGMP/GLP/ICH/USFDA/ISO guidelines and aligned with
    internal and industry quality standards.
  • Manage and/or support the OOS/OOT/OOE and any other analytical related
    Deviations, CAPAs, Change Control, etc in close collaboration with QA /RA
    department and ADQC team.
  • Prepare, review and evaluate internal and third party SOPs, WIs, procedures
    and guidelines
  • Ensure high quality analytical documentation for submission to Health
    Authorities
  • Train regularly the ADQC team on quality control measures and requirements
    regarding analytical testing procedures, equipment qualification, data recording,
    laboratory management, etc

Qualifications
•Ph.D. or equivalent in Analytical Chemistry, Biochemistry or related discipline
applied to the analysis of large molecules

  • Quality Control or analytical QC-related expertise (≥ 10 years) in the
    pharmaceutical/biotech field preferably interacting within multi-disciplinary
    teams
  • Deep working knowledge of method development and validation of analytical
    methods for New Biological Entities
  • Successful record of interaction with Regulatory Affairs and expertise in
    applicable regulations in the field of analytics (i.e. Ph.Eur./USP monographs
    and chapters, and cGMP/GLP/ICH/USFDA/ISO guidelines)
  • Personal features include:
  • Team spirited with strong organizational, problem-solving and analytical skills
  • Autonomous with good judgment and ability to make decisions in a timely
    manner
  • Demonstrated ability to manage multiple tasks at once
  • Strong interpersonal skills to build efficient relationships and communication
    within the team and at the interface with other departments
  • Proven Leadership ability and project management skills
  • Good spoken and written English are required

Would be a plus:

  • Expertise in the Quality Control of New Chemical Entities
  • Experience in Quality Assurance

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