CMC Program Manager: Schedule & Delivery Lead

Viking Therapeutics

San Diego (CA)

Sur place

USD 130 000 - 150 000

Plein temps

Il y a 8 jours

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Résumé du poste

Viking Therapeutics, Inc. in San Diego, CA, seeks a Program Manager, CMC to drive integrated CMC deliverables across clinical programs.

You will own day-to-day schedules with external manufacturers and internal CMC teams, ensuring a single source of truth and clear visibility for Quality, Regulatory, and cross-functional partners. You will lead CMC meetings, coordinate document review and approval, support risk management and scenario planning, and help leadership make timely decisions, gaining

Qualifications

  • BA/BS in science or related discipline; advanced degree a plus.
  • 2+ years in pharma/biotech or regulated project management.
  • Experience supporting cGMP manufacturing activities or CMC projects.
  • Exposure to IND or NDA submission activities.

Responsabilités

  • Develops and maintains integrated CMC schedules across external manufacturers and internal teams.
  • Maintains a single source of truth for manufacturing schedules and communicates priorities.
  • Facilitates CMC meetings, agendas, summaries, and action-item tracking.
  • Creates and maintains CMC dashboards, plans, and schedules for project teams.
  • Supports risk management by identifying schedule risks and updating the risk log.
  • Prepares schedule impact analyses for scenario planning and decisions.
  • Builds collaborative relationships with internal and external partners.
  • Applies project management best practices and suggests process improvements.
  • Other duties as assigned.

Connaissances

Clear written and verbal communication
Reliability and accountability
Integrity and discretion
Prioritization and task management
Strong organizational skills
Experience with PM tools

Formation

BA/BS in science or related field
MS/PhD is a plus

Outils

Microsoft Project
Smartsheet
SharePoint

Description du poste

Viking Therapeutics, Inc. in San Diego, CA, seeks a Program Manager, CMC to drive integrated CMC deliverables across clinical programs.

You will own day-to-day schedules with external manufacturers and internal CMC teams, ensuring a single source of truth and clear visibility for Quality, Regulatory, and cross-functional partners. You will lead CMC meetings, coordinate document review and approval, support risk management and scenario planning, and help leadership make timely decisions, gaining

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