Head of Biologics

Job Description

Job Description

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 to lead the selection and development of therapeutic proteins produced using Neion Bio’s egg-based biomanufacturing platform. This person will own Neion Bio's biologics portfolio and lead our therapeutic protein programs from molecule selection through regulatory approval. This person helps us decide which proteins we pursue and then leads the cross-functional programs that get them to the market.

This is a leadership role for someone who has run biologics programs end to end. You will be the single accountable owner for program outcomes, setting strategy and stage-gate criteria, driving decisions across process development, analytical, regulatory, and manufacturing, and managing our external partner network helping us execute on the work. The ideal candidate has deep experience in biologics development, can critically evaluate protein quality and process data, and has led cross-functional programs through regulatory interactions

This person will initially lead a small team of downstream process development and analytical scientists and will play a central role in building Neion Bio's broader protein organization

Key Responsibilities

• Own the biologics portfolio from technical lens: evaluate and prioritize candidate molecules against technical feasibility on our platform and regulatory pathway. 
• Lead Neion Bio’s protein development function, including downstream process development, analytical development, product characterization, and regulatory strategy and interactions
• 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
• Serve as the technical 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

Why Neion Bio?

We are on a mission to reimagine the way in which complex biological molecules are produced to transform human health. At Neion Bio, you will play a pivotal role in an early-stage, fast-growing company, working alongside leading scientists and entrepreneurs. You will have the opportunity to participate in the enormous potential upside while having a significant impact on the world.

This is a rare opportunity to build the biologics portfolio for an entirely new biomanufacturing platform. You will help decide which therapeutics get made in chicken eggs, how they get developed, and how they reach patients — while building the scientific, regulatory, and organizational foundation for a new category of medicine manufacturing.

Requirements

• Ph.D. in biochemistry, chemical engineering, bioengineering, pharmaceutical sciences, analytical chemistry, or a related field, with 10+ years of relevant industry experience
• Deep experience in biologics development, with a technical foundation in downstream process development, analytical development, protein characterization, or a closely related field
• Deep technical knowledge of protein characteristics, especially glycosylation and other post translational modifications 
• Substantial technical ownership of at least one biologic program through a major late-stage regulatory milestone, such as BLA or MAA submission, approval, process validation, or commercial readiness.
• Experience managing scientists and leading cross-functional technical teams
• Experience selecting and managing CROs, CDMOs, analytical laboratories, and other external development partners

Benefits

Compensation: base salary is expected to be $170K-$230K depending on experience, with additional bonus compensation, equity compensation, and benefits including health insurance, dental insurance, vision insurance, and 401(k).