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.
Tasks
Process 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.
Requirements
Required
- 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 For
Hands-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.