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
Requirements- 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
- 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
BenefitsCompensation: 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).
