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Abzena Inc.

Director, Technical Solutions & Program Design

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Job Description

Director, Technical Solutions & Program Design Abzena Inc. - 2.4 Raleigh, NC Job Details Full-time 18 hours ago Qualifications Pharmaceutical regulatory compliance GMP Bachelor's degree Bioprocessing Chemistry, manufacturing & controls Manufacturing Full Job Description With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. 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, ADCs, AOCs and other complex modalities. This position turns customer objectives into executable, competitive programs that drive business growth and successful client outcomes. 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. 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. What Success Looks Like High-quality proposals delivered on time. Strong conversion of opportunities into awarded programs. Excellent client experience and trusted-advisor relationships. Effective alignment between customer expectations and operational execution.
FLSA:
Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.

Benefits

  • Dental Insurance