Director, CMC Lead — Multispecific Antibodies (Remote)

Shennon Biotechnologies; San Francisco (CA); On-site; USD 260,000 - 420,000; Full time

Job summary

Shennon Biotechnologies is seeking a director-level CMC leader to own end-to-end CMC for a trispecific TCE program advancing toward IND. You will manage CDMOs across US, Europe, and China, build the integrated CMC plan, and ensure regulatory readiness.

The role is hands-on, with budget ownership, quality oversight, and collaboration with discovery and clinical teams. Remote work is allowed for this program, with potential co-location in San Francisco as programs expand.

Qualifications

• PhD or advanced degree with extensive biologics CMC experience.
• Experience selecting and steering CDMOs and RFP writing.
• Hands-on CMC leadership for IND-enabling programs.
• Quality agreements, release decisions, and GMP oversight.
• Regulatory interactions and Module 3 experience helpful.
• Global CDMO collaboration across US/Europe/China.

Responsibilities

• Build an integrated CMC plan from candidate nomination to first in human.
• Run CDMO selection via competitive RFPs across regions.
• Negotiate and manage chosen CDMOs for development and transfer.
• Own quality, batch records, deviations, OOS and releases.
• Own CMC budget, forecast, and alignment with cash plan.
• Lead analytical and release strategy and regulatory discussions.
• Secure GLP tox material and downstream clinical supply.
• Author Module 3 and participate in agency meetings.
• Identify format-driven CMC risks and shape strategies.

Skills

CDMO management

RFP writing

Quality assurance

Regulatory fluency

Biologics CMC

Timeline judgment

Education

PhD in a relevant discipline

BS/MS with 12+ years in biologics CMC

Job description

Shennon Biotechnologies is seeking a director-level CMC leader to own end-to-end CMC for a trispecific TCE program advancing toward IND. You will manage CDMOs across US, Europe, and China, build the integrated CMC plan, and ensure regulatory readiness.

The role is hands-on, with budget ownership, quality oversight, and collaboration with discovery and clinical teams. Remote work is allowed for this program, with potential co-location in San Francisco as programs expand.