Job Detail

Analytical Project Leader (NBE)
Description

Function Analytical Project Leader in New Biological Entities (NBE)
Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne
hr@acimmune.com
Percentage 100 % - available immediately
Reporting Line Analytical Development and Quality Control
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 Analytical Project Leader to
support its CMC product development programs.
The candidate must possess a strong scientific background in Analytical
Chemistry and must have drug development experience, preferably for
monoclonal antibodies and within a CMC and QC setting. He/she must
have a clear record of scientific accomplishments and ability to interact
across functions within a dynamic matrix organization.
Job description Analytical Project Leader (NBE) Responsibilities:
Lead and manage the analytical-related activities (release, stability,
characterization, method development/transfer/validation, specification
setting, etc) of Drug Products, APIs and raw materials

• Coordinate and/or perform the analytical-related activities to support
  Research and Manufacturing in house and at third parties


• Depending on project needs and growth, supervise and coach
  technician(s)


• Prepare, review and evaluate internal and third party scientific and
  technical protocols and reports as well as QC documents, including
  data consolidation and analysis


• Support Analytical Development and QC department in designing and
  monitoring the strategy, timelines and budget for assigned projects


• Support QA, Regulatory and Manufacturing departments in
  monitoring and evaluation of quality-related events (e.g. OOS,
  deviations, change controls)


• Ensure high quality analytical documentation for submission to
  Health Authorities


• Present data at international scientific conferences and publishing in
  scientific peer-reviewed journals

Qualifications The candidate should have the following qualifications:

• Ph.D. or equivalent in Analytical Chemistry, Biochemistry, Biology or
  a related discipline applied to large molecules


• Analytical, QC or research related expertise (≥ 5 years) in the
  pharmaceutical/biotech field of New Biological Entities, preferably
  interacting within multi-disciplinary teams


• Successful industrial experience in physico-chemical methods,
  protein characterization and analytical project management for
  monoclonal antibodies


• Excellent knowledge and hand-on expertise on a wide variety of
  physicochemical and bioanalytical techniques (eg HPLC/UPLC, LC-
  MS, SEC, electrophoresis, MALDI, IR, CD, ELISA, etc)


• Strong understanding of CMC analytical strategy for NBE (e.g.
  antibodies, therapeutic proteins and protein conjugates) at all clinical
  phases is an asset

Analytical Project Leader (NBE)

• Experience in Regulatory Affairs and Quality applied to analytics (i.e.
  Ph.Eur./USP monographs and chapters, and ICH/FDA guidelines) is
  a plus


• High level of analytical troubleshooting and problem solving skills


• Proactive and flexible team player, with ability to manage parallel
  activities, within different projects in a fast-paced environment


• Advanced communication (including scientific/technical) skills, both
  verbal and written


• Fluency in English; French and a third language are assets