Head of Biologics Development & CMC

Neion Bio•New York, NY

7h•$170,000 - $230,000

About The Position

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. 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.

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

Nice To Haves

Deep experience in biologics (and in particular biosimilars) development

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