Quality Control Lead

Quality Control Lead - NEW
Description
Function
Quality Control Lead
Location / Contact
AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben Percentage
100 %
Reporting Line
Analytical Development & Quality Control (ADQC) Group Leader AC Immune is a clinical-stage Swiss Biotech Company focused on the development Overview 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. - Lead and manage analytical method transfer, qualification and/or validation Job description 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