CMC Program Manager, Biotech (Clinical Manufacturing)

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Program Manager, CMC to drive the coordinated execution of Chemistry, Manufacturing, and Controls deliverables across clinical programs.

You will own day-to-day schedules with external manufacturers and internal CMC teams, and ensure a single source of truth for manufacturing activities. This role collaborates with Quality, Regulatory, and other partners, facilitates CMC meetings, reviews documents, and supports risk management and decision-making.

Qualifications

• BA/BS degree in a scientific or related discipline; an advanced degree (MS, PhD) is a plus.
• Minimum of 2 years of experience in the pharmaceutical, biotech, or CDMO industry, or in regulated project management.
• Experience supporting cGMP manufacturing activities or CMC projects.
• Exposure to IND or NDA submission activities.

Responsibilities

• Develops and maintains integrated CMC schedules that capture activities, dependencies, milestones, and deliverables across external manufacturing partners and internal teams.
• Maintains a single source of truth for manufacturing schedules and communicates current priorities to Quality, Regulatory, and other partner functions.
• Facilitates internal and CDMO CMC meetings, including scheduling, agendas, meeting summaries, and tracking action items to completion.
• Creates, organizes, and maintains CMC dashboards, plans, and schedules accessible to project teams, and coordinates the timely review and approval of CMC documents.
• Supports CMC risk management by identifying schedule risks early, maintaining the risk log, and escalating to program leadership.
• Prepares schedule impact analyses to support scenario planning and decision-making.
• Builds trusted, collaborative working relationships with internal team members and external manufacturing partners.
• Applies project management best practices and recommends process improvements.
• Other duties as assigned.

Skills

Communication skills

Project management

Reliability

Integrity

Attention to detail

Organizational skills

Education

BA/BS degree

MS or PhD degree (advanced)

Tools

Microsoft Project

Smartsheet

SharePoint

Job description

Viking Therapeutics, Inc. is seeking a Program Manager, CMC to drive the coordinated execution of Chemistry, Manufacturing, and Controls deliverables across clinical programs.

You will own day-to-day schedules with external manufacturers and internal CMC teams, and ensure a single source of truth for manufacturing activities. This role collaborates with Quality, Regulatory, and other partners, facilitates CMC meetings, reviews documents, and supports risk management and decision-making.