Head of Biologics Development & CMC

About Neion Bio:

Neion Bio is harnessing nature’s best molecular factory, the chicken egg, to make medicine affordable, accessible, and resilient. We turn farms into medicine factories using cutting edge genetic engineering and stem cell technology. These “living bioreactors” are fully autonomous 3D biomolecular printers that operate on existing industrial-scale infrastructure. Our platform can rapidly and scalably produce almost any protein, provide national resilience to drug shortages and de-risk complex supply chains, and ultimately take advantage of novel biological environments to solve unmet medical needs. Biomanufacturing, reinvented. Medicine, democratized.

Role Summary:

We are looking for an exceptional Head of Biologics Development & CMC to lead the development of therapeutic proteins produced using Neion Bio’s egg-based biomanufacturing platform. This person will own Neion Bio’s protein development and CMC strategy, spanning downstream process development, analytical development, product characterization, and regulatory CMC.

This is a role for a technically rigorous and highly collaborative leader who can move fluidly between scientific and regulatory strategy and hands-on problem solving. The ideal candidate has deep experience in biologics (and in particular biosimilars) development, can critically evaluate protein quality and process data, and has led cross-functional CMC programs through regulatory interactions. This person will initially manage a small team of downstream process development and analytical scientists and will play a central role in building Neion Bio’s broader protein development organization.

Key Responsibilities:

Lead Neion Bio’s protein development function, including downstream process development, analytical development, product characterization, and CMC strategy

Define product-specific critical quality attributes and establish risk-based strategies for evaluating their potential impact on safety, efficacy, pharmacokinetics, immunogenicity, and biological function

Lead the design and interpretation of comparative analytical assessment and biosimilarity programs, including reference-product characterization, lot-selection strategy, analytical similarity, and structure–function studies

Provide technical oversight of purification-process development

Select and manage CROs, CDMOs, consultants, and other external technical partners, ensuring scientific quality, appropriate study design, and timely execution

Lead CMC development planning, including program timelines, technical risk assessments, budgets, resource plans, and decision-making frameworks.

Serve as the technical CMC lead in interactions with FDA and other regulatory agencies, including preparation for meetings, responses to agency questions, and implementation of regulatory feedback

Contribute to portfolio strategy, program selection, development timelines, budgets, hiring, and organizational planning