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About the Role

Lead the development of therapeutic proteins using Neion Bio’s egg-based biomanufacturing platform. Own the protein development and CMC strategy, encompassing downstream process development, analytical development, product characterization, and regulatory CMC. This role requires a technically rigorous and collaborative leader adept at scientific and regulatory strategy, as well as hands-on problem-solving. The ideal candidate will have extensive experience in biologics development, particularly biosimilars, and a proven ability to evaluate protein quality and process data, having led cross-functional CMC programs through regulatory interactions. Initially, this role will manage a small team of scientists and will be instrumental in building Neion Bio’s broader protein development organization.

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.

Skills

Biologics development
Biosimilars development
Downstream process development
Analytical development
Product characterization
Regulatory CMC
Protein quality evaluation
Process data evaluation
Cross-functional CMC program leadership
Protein characteristics
Glycosylation
Post-translational modifications

Location

Remote

Work Type

Full-time

Experience Level

10+ years of relevant industry experience
13+ years of experience (M.S.)
15+ years of experience (B.S.)

Education Level

Ph.D. in biochemistry, chemical engineering, bioengineering, pharmaceutical sciences, analytical chemistry, or a related field
M.S.
B.S.

Salary/Compensations

$170K-$230K

Benefits

Bonus compensation
Equity compensation
Health insurance
Dental insurance
Vision insurance
401(k)

About the Company

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.