Biologics Development & CMC Leader

Neion Bio, Inc.; New York (NY); On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

Neion Bio, Inc. is seeking a Head of Biologics Development & CMC to lead protein development using our egg-based biomanufacturing platform.

You will own the protein development and CMC strategy, spanning downstream process development, analytical development, product characterization, and regulatory CMC. This highly collaborative leader will bridge science and regulation, evaluate protein quality and process data, and guide cross-functional teams through late-stage regulatory milestones and

Qualifications

• Ph.D. in a related field with 10+ years of industry experience
• M.S. with 13+ years or B.S. with 15+ years of experience
• Deep biologics development experience with a focus on downstream/analytical development
• Expertise in protein characteristics, glycosylation and PTMs
• Led at least one biologic program through a major late-stage regulatory milestone (e.g., BLA/MAA)
• Experience managing scientists and leading cross-functional teams
• Experience selecting and managing CROs/CDMOs and external partners

Responsibilities

• Lead protein development function including downstream process development, analytical development, product characterization, and CMC strategy
• Define product-specific critical quality attributes and risk-based strategies
• Lead the design and interpretation of comparative analytical assessments and biosimilarity programs
• Provide technical oversight of purification-process development
• Select and manage CROs, CDMOs, consultants, and other external partners
• Lead CMC development planning including timelines, risk assessments, budgets, and resources
• Serve as technical CMC lead in interactions with FDA and other regulatory agencies
• Contribute to portfolio strategy, program selection, development timelines, budgets, hiring, and organizational planning

Skills

Biologics development

Downstream process development

Analytical development

Protein characterization

Glycosylation knowledge

Regulatory CMC strategy

FDA interactions

Team leadership

Vendor management (CROs/CDMOs)

Education

Ph.D. in Biochemistry / Chemical Engineering / Bioengineering / Pharmaceutical Sciences / Analytical Chemistry

M.S. in related field (with 13+ years experience)

B.S. in related field (with 15+ years experience)

Job description

Neion Bio, Inc. is seeking a Head of Biologics Development & CMC to lead protein development using our egg-based biomanufacturing platform.

You will own the protein development and CMC strategy, spanning downstream process development, analytical development, product characterization, and regulatory CMC. This highly collaborative leader will bridge science and regulation, evaluate protein quality and process data, and guide cross-functional teams through late-stage regulatory milestones and