Head of Biologics Development & CMC

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
• 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

Required Qualifications

• Ph.D. in biochemistry, chemical engineering, bioengineering, pharmaceutical sciences, analytical chemistry, or a related field, with 10+ years of relevant industry experience; an M.S. with 13+ years of experience, or a B.S. with 15+ years of experience
• Deep experience in biologics development, with a technical foundation in downstream process development, analytical development, protein characterization, or a closely related field
• 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

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 protein development function for an entirely new biomanufacturing platform. You will help determine how therapeutics produced in chicken eggs are purified, characterized, understood, and advanced toward patients, while building the scientific and regulatory foundation for a new category of medicine manufacturing.

Pay

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).