Director of Biologics Solutions & Program Design

Abzena; Raleigh (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Abzena is seeking a commercially minded scientific leader to partner with Business Development, clients and technical teams to design integrated development and manufacturing solutions for biologics and related modalities. This role translates customer objectives into executable programs that drive growth and client success.

The candidate will lead technical discussions, design programs from early development through GMP manufacturing, review RFPs, and coordinate experts across development,

Qualifications

• BS degree in a relevant life science or engineering discipline; MS or PhD preferred.
• 10+ years of biotechnology, pharmaceutical or CDMO experience.
• Demonstrated expertise in biologics and/or bioconjugate development and manufacturing.
• Experience leading client-facing technical and commercial discussions.
• Strong understanding of CMC development, GMP manufacturing and regulatory expectations.

Responsibilities

• Lead technical discussions with prospective and existing clients.
• Design integrated development and manufacturing programs from early development through GMP manufacturing and commercial readiness.
• Review RFPs, assess technical feasibility and define scope, timelines, risks and resource requirements.
• Partner with Proposal Development to create proposals, budgets, timelines and Statements of Work.
• Coordinate cross-functional subject matter experts across development, manufacturing, quality and regulatory functions to align on final client proposals.
• Present technical solutions during proposal reviews, due diligence meetings and site visits.
• Serve as the technical lead through project award and handoff to execution teams.
• Continuously improve proposal tools, templates and standard work practices.

Skills

Biologics development

CDMO experience

Client-facing discussions

CMC knowledge

GMP manufacturing

Education

BS in life science or engineering

MS or PhD preferred

Job description

Abzena is seeking a commercially minded scientific leader to partner with Business Development, clients and technical teams to design integrated development and manufacturing solutions for biologics and related modalities. This role translates customer objectives into executable programs that drive growth and client success.

The candidate will lead technical discussions, design programs from early development through GMP manufacturing, review RFPs, and coordinate experts across development,