Director, CMC Strategy & CDMO Leadership - Remote

Shennon Biotechnologies; United States; Remote; USD 260,000 - 380,000; Full time

Job summary

Shennon Biotechnologies is seeking a Director-level CMC lead to own end-to-end CMC activities for a trispecific TCE program advancing toward IND. The role requires hands-on management, not a pure executive function, reporting to the Head of Research (interim) and then CSO.

You will own the integrated CMC plan, oversee CDMO selection and negotiation, ensure quality and regulatory readiness, and drive module 3 authoring and agency meetings as needed.

Qualifications

• PhD in a relevant discipline or BS/MS with 12+ years in biologics CMC.
• Experience selecting and managing CDMOs, including writing RFPs and evaluating quotes.
• Quality fluency to negotiate quality agreements and release decisions on outsourced GMP material.
• Module 3 authoring or QC, and regulatory fluency for agency meetings.

Responsibilities

• Build a single integrated CMC plan from development to first-in-human.
• Run CDMO RFP process across US, Europe, and China for cross-vendor comparability.
• Negotiate and manage CDMOs for cell line development, process development, analytical development, and tech transfer.

Skills

CDMO management

CMC strategy

Regulatory affairs

Contract negotiation

Budget forecasting

Education

PhD in a relevant discipline

BS/MS with 12+ years in biologics CMC

Job description

Shennon Biotechnologies is seeking a Director-level CMC lead to own end-to-end CMC activities for a trispecific TCE program advancing toward IND. The role requires hands-on management, not a pure executive function, reporting to the Head of Research (interim) and then CSO.

You will own the integrated CMC plan, oversee CDMO selection and negotiation, ensure quality and regulatory readiness, and drive module 3 authoring and agency meetings as needed.