Associate Director, Biologics CMC Process Development

Valid8 Financial, Inc.; South San Francisco (CA); On-site; USD 160,000 - 200,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

Life Insurance

HSA/FSA

401k plan

PTO

Job summary

TCG Labs‑Soleil is seeking a Senior Manager / Associate Director, Process Development to lead CMC biologics DS/DP process development and manufacturing efforts. You will oversee technical direction, scale‑up, tech transfer, and cross‑functional collaboration with QA, regulatory, and external CDMOs.

The role emphasizes strong project management, regulatory insight (FDA/EMA/ICH), and the ability to drive on‑time clinical material delivery in a fast‑paced startup environment.

Qualifications

• BS/MS/PhD in biochemistry or related field.
• Experience leading biologics CMC development/manufacturing.
• Experience with external CDMOs/CROs and vendors.
• Strong project management with cross‑functional communication.

Responsibilities

• Technical ownership for DS or DP CMC process development/manufacturing.
• Lead downstream and/or upstream DSP/DP scale‑up, tech transfer, and GMP manufacturing.
• Support regulatory submissions including IND/IMPD Module 3 sections.
• Coordinate with QA and Regulatory to ensure batch disposition and submission readiness.
• Develop and drive integrated CMC project plans, timelines, and budgets.

Skills

Biologics CMC

Project management

CDMO management

Regulatory knowledge

Cross-functional

Education

BS/MS/PhD in relevant field

Tools

Smartsheet

MS Project

Veeva

SharePoint

Job description

TCG Labs‑Soleil is seeking a Senior Manager / Associate Director, Process Development to lead CMC biologics DS/DP process development and manufacturing efforts. You will oversee technical direction, scale‑up, tech transfer, and cross‑functional collaboration with QA, regulatory, and external CDMOs.

The role emphasizes strong project management, regulatory insight (FDA/EMA/ICH), and the ability to drive on‑time clinical material delivery in a fast‑paced startup environment.