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
• 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

About the role

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.

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

Pay

USD 170k-230k / year + Equity

Schedule

N/A