(Senior) Director, Process Development

GlycoEra AG

  • Wädenswil, Zürich
  • Unbefristet
  • Vollzeit
  • 8 Tage her
The (Senior) Director, Process Development owns end-to-end process development for Glycoera's biologics pipeline, from early-stage design through clinical trial material supply. This is a hands-on leadership role with deep personal accountability for downstream process excellence, CDMO tech transfer, and enabling clinical programs to move fast without compromising quality. The right candidate is a practitioner-level expert who understands commercial viability but is laser-focused on the tradeoffs that matter now: speed, quality, and fit-for-purpose processes for the clinic.TasksProcess Development Leadership
  • Lead upstream and downstream process development for therapeutic proteins across Glycoera's expression platform, with hands-on emphasis on downstream purification.
  • Design, develop, and optimize robust, scalable processes — balancing speed to clinic with product quality, process understanding, and long-term manufacturability.
  • Develop purification processes for Fab, mAb, and novel protein scaffolds, including capture, intermediate and polishing chromatography, and UF/DF for high-concentration subcutaneous formulations.
  • Ensure all processes are CMC-compliant and fit-for-purpose, supporting rapid IND-enabling and clinical supply timelines.
Tech Transfer & CDMO Partnership
  • Lead technology transfer to CDMOs with a first-time-right philosophy — establishing rigorous transfer packages, process characterization data, and site readiness criteria.
  • Serve as primary technical interface with CDMO partners during transfer, scale-up, and GMP clinical manufacturing campaigns.
CMC Regulatory & Team
  • Define process validation and characterization strategy in a stage appropriate manner, aligned with ICH guidelines and global regulatory expectations; author and review CMC sections of regulatory submissions.
  • Build and develop the Process Development team; foster scientific excellence, accountability, and a culture that thrives in a lean, fast-moving environment.
RequirementsRequired
  • PhD in biochemistry, chemical engineering, or related discipline.
  • 12+ years of CMC process development experience for recombinant biologics.
  • Deep expertise in downstream purification at industrial scale — chromatography, UF/DF, and high-concentration formulation for subcutaneous delivery.
  • Solid upstream process development experience and demonstrated ability to integrate end-to-end processes for quality and clinical supply.
  • Proven success leading technology transfer to GMP CDMO manufacturing for clinical trial supply.
  • Hands-on, self-driven, and comfortable making and owning tradeoff decisions in ambiguous, resource-constrained environments.
Preferred
  • Experience with Fab, mAb, and novel scaffold modalities across multiple expression systems.
  • Background in autoimmune, immunology, or adjacent therapeutic areas.
  • Series B/C biotech experience; fluency operating lean, CDMO-reliant CMC organizations.
What We're Looking ForHands-on expert:Never too senior for the data; equally effective at the bench and in strategic discussions.Speed-quality navigator:Makes smart tradeoffs to keep clinical programs moving — without losing sight of what matters for patients and regulators.Builder mentality:Thrives in ambiguity, energized by building rather than maintaining, comfortable without a large support infrastructure.First-time-right mindset:Approaches CDMO transfers with rigor and foresight — anticipates failure modes before they materialize.If this role matches your profile, please upload your CV and motivation letter.GlycoEra AGGlycoEra is developing biologics to selectively target the root cause of many autoimmune diseases: a specific circulating protein (autoantibody). Our approach enables us to degrade targets rapidly, selectively, and deeply while avoiding broader dampening of the immune system. This offers many potential benefits over existing broad-spectrum immune-suppressing therapies, including an improved safety profile and the potential for earlier disease intervention – which could improve patient quality of life, limit long-term complications and lower overall healthcare costs.Our best-in-class, extracellular degrader BiND™ platform (Biologic Natural Degrader), allows us to target and rapidly, deeply degrade any circulating protein of interest regardless of therapeutic area – such as an autoantibody in autoimmune disease, a circulating factor inducing inflammation or a protein aggregate in neurological disease.

GlycoEra AG