Remote CMC Asset Lead — Biologics (Bispecifics)

ShennonBio; San Francisco (CA); Remote; USD 200,000 - 320,000; Full time

Job summary

ShennonBiotechnologies is seeking a director-level CMC leader to own end-to-end CMC for a trispecific TCE program, from discovery handoff through IND. The role is hands-on and reports to the Head of Research, with potential to become a full-time, SF-based position after initial consulting.

The role requires regulating CMC strategy, budget ownership, and CDMO negotiations across US, Europe, and China, including regulatory meetings and Module 3 authoring.

Qualifications

• PhD in a relevant discipline or BS/MS with 12+ years in biologics CMC.
• Proven track record developing CMC content from development to IND.
• Experience selecting and managing CDMOs and writing RFPs.
• Quality agreements, release decisions and GMP material knowledge.
• Regulatory fluency to defend CMC sections in meetings.
• Experience working with CDMOs in multiple regions (US, Europe, China).
• Ability to forecast budgets and assess line-item costs.

Responsibilities

• Build an integrated CMC plan from development to first-in-human.
• Lead CDMO RFPs and manage multiple vendors for comparability.
• Negotiate quality agreements and oversee GMP release decisions.
• Own CMC budget, forecast, and cost optimization.
• Define analytical and release strategy including potency assays.
• Coordinate GLP tox material and downstream clinical supply.
• Contribute to Module 3 authoring and pre-IND briefing content.
• Flag CMC risks early and advise on format choices.

Skills

CDMO management

RFP writing

Quality negotiation

Regulatory fluency

Project leadership

Education

PhD in biology/biologics

BS/MS with 12+ years in biologics CMC

Job description

ShennonBiotechnologies is seeking a director-level CMC leader to own end-to-end CMC for a trispecific TCE program, from discovery handoff through IND. The role is hands-on and reports to the Head of Research, with potential to become a full-time, SF-based position after initial consulting.

The role requires regulating CMC strategy, budget ownership, and CDMO negotiations across US, Europe, and China, including regulatory meetings and Module 3 authoring.