Director​/Senior Director, Biologics Drug Substance Development

Ollin is a biotechnology company developing differentiated, impactful therapeutics for the treatment of serious, common ophthalmic diseases. Our approach is to identify, acquire and develop these therapeutic programs with the highest levels of quality, scientific rigor, and transparency. We are targeting biologies that we believe will make meaningful improvements to patient care and treatment outcomes, and we will prospectively utilize the latest technologies in ophthalmic imaging and data sciences to inform our drug development activities.

We are building out our clinical team to support our phase 3 programs of OLN
324 in neovascular age-related macular degeneration (NAMD) and diabetic macular edema (DME), as well as support work on our earlier stage program, OLN
102, in thyroid eye disease and Graves’ disease.

• Own the technical program.
  
  You’ll lead cell line, upstream, and downstream process development from early-stage through commercial manufacturing. You won’t just oversee it, but shape the strategy and own the outcomes.
• Join at a pivotal moment.
  
  Our CMC organization is still being built, so you’ll have real influence over how we do process development, validation, and tech transfer for years to come.
• Work on programs that matter.
  
  A Phase 3 asset in nAMD and DME, plus an earlier-stage thyroid eye disease program. Your work translates directly into treatments for diseases that affect millions.
• Seniority with real scope.
  
  You’ll manage technical teams, direct CDMO partners, and be a key technical voice in regulatory interactions and BLA submission.

• Lead cell line, cell culture, and purification process development for biologics drug substance.
• Provide technical leadership and strategic direction for drug substance development across programs.

• Lead late-stage process characterization to establish process understanding, identify critical process parameters (CPPs), and develop robust process control strategies.
• Lead process validation/PPQ, including validation strategy, protocol development, execution, data analysis, and troubleshooting.

• Lead scale-up, technology transfer, and manufacturing readiness activities from development through commercial manufacturing.
• Manage external development and manufacturing partners/CDMOs and ensure successful execution of technical activities and program milestones.
• Identify technical risks and develop effective mitigation strategies to support program timelines and successful regulatory and manufacturing outcomes.

• Support preparation and submission of BLA/MAA CMC documentation, with a focus on drug substance process development, characterization, validation, and manufacturing.
• Provide technical leadership during regulatory interactions and preparation of responses to agency questions.

• Manage staff across cell line, upstream, and downstream process development.
• Work closely with Quality, Regulatory, Manufacturing, and external partners/CDMOs.

• Ph.D. or M.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or a related scientific discipline.
• 10+ years of industry experience in biologics process development and CMC, with increasing levels of technical and leadership responsibility.
• Strong experience in cell line, upstream, and/or downstream process development, with a broad understanding of biologics drug substance manufacturing.
• Demonstrated experience leading late-stage process characterization and process validation/PPQ.
• Direct experience supporting or leading a BLA submission and associated regulatory interactions.
• Experience with…