Associate Director, Downstream DS Manufacturing

Doist; Brisbane (CA); On-site; USD 175,000 - 210,000; Full time

Job summary

Vera Therapeutics in Brisbane, California, is seeking an Associate Director, Drug Substance Manufacturing – Downstream Process to lead all downstream DS manufacturing activities, technology transfer, and regulatory submissions for biologics and related products. This senior role reports to the VP of Commercial Manufacturing Operations and requires strong leadership and cross‑functional collaboration.

The candidate will oversee scale‑up, validations, PPQ campaigns, CPV, and lifecycle management,

Qualifications

• MS in life sciences or engineering with a minimum of 5 years in biologics drug substance downstream processes and cGMP manufacturing operations.
• Experience in technology transfer, process validation, and regulatory submissions for global markets.
• Strong leadership and cross-functional management of CMC-related programs.

Responsibilities

• Technical oversight of downstream DS manufacturing at CMOs.
• Lead investigations, deviations, CAPA implementation, and campaign readiness.
• Author and review CMC sections for regulatory submissions and PPQ readiness.

Skills

Downstream processing

Tech transfer

Regulatory submissions

GMP manufacturing

Process optimization

Education

MS in life sciences

BS with 8 years

Tools

MS Project

Job description

Vera Therapeutics in Brisbane, California, is seeking an Associate Director, Drug Substance Manufacturing – Downstream Process to lead all downstream DS manufacturing activities, technology transfer, and regulatory submissions for biologics and related products. This senior role reports to the VP of Commercial Manufacturing Operations and requires strong leadership and cross‑functional collaboration.

The candidate will oversee scale‑up, validations, PPQ campaigns, CPV, and lifecycle management,