Remote Associate Director, Upstream Drug Substance

Vera Therapeutics, Inc.; United States; Remote; USD 175.000 - 210.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Zusammenfassung

Vera Therapeutics, Inc. is seeking an Associate Director, Drug Substance Manufacturing – Upstream Process, remote in the United States.

This leadership role oversees biologics upstream manufacturing, technology transfer, and lifecycle management for commercially approved products, partnering with global CMOs and cross‑functional teams. The candidate will author and review CMC regulatory submissions, drive process improvements, and ensure GMP/ICH compliance across sites, with strong project

Qualifikationen

• MS in life sciences or engineering or related field with relevant experience in biologics upstream processes.
• Hands-on upstream processing including cell culture, harvest, and cell bank management.
• Experience with technology transfer, process validation, and GMP manufacturing.
• Experience leading CMC programs, CDMO management, and regulatory interactions.

Aufgaben

• Serve as primary technical interface with global CMOs for upstream manufacturing.
• Lead investigations for deviations, root cause analyses, and CAPA.
• Supervise campaign readiness, change management, and process optimization discussions.
• Oversee technology transfer and process qualification across CMO sites.
• Author and review validation protocols, reports, and technical documentation.
• Drive continuous improvement across upstream processes and benchmarking.
• Support CMC/regulatory submissions (NDA, BLA, MAA) and post‑approval changes.

Kenntnisse

Leadership

MSAT experience

Cell culture

Process validation

Risk management

Regulatory knowledge

GMP familiarity

Data analysis

MS Project

Ausbildung

MS in life sciences or engineering

BS with 8 years experience

Tools

MS Project

Jobbeschreibung

Vera Therapeutics, Inc. is seeking an Associate Director, Drug Substance Manufacturing – Upstream Process, remote in the United States.

This leadership role oversees biologics upstream manufacturing, technology transfer, and lifecycle management for commercially approved products, partnering with global CMOs and cross‑functional teams. The candidate will author and review CMC regulatory submissions, drive process improvements, and ensure GMP/ICH compliance across sites, with strong project