Program Manager, CMC

Viking Therapeutics, Inc.

San Diego (CA)

On-site

USD 120,000 - 170,000

Full time

3 days ago
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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 is a clinical-stage biotechnology company advancing a next-generation portfolio of therapies for obesity and metabolic disease. We are developing treatments to help patients achieve meaningful, lasting improvements in health by treating obesity first. Our therapies are designed to support the long-term health benefits of weight loss, including cardiovascular health, improved physical function, and quality of life.

Description

As Program Manager, CMC, you will drive the coordinated execution of Chemistry, Manufacturing, and Controls (CMC) deliverables across Viking’s clinical-stage programs. You will own day-to-day schedules for external manufacturing partners and internal CMC teams, maintain a reliable single source of truth for manufacturing activities, and ensure Quality, Regulatory, and other cross-functional partners have clear visibility into priorities, dependencies, and timelines. You will facilitate CMC meetings, coordinate document review and approval, and support risk management, scenario planning, and timely decision-making by program leadership. This role provides broad exposure to multiple programs and the opportunity to deepen program management expertise while working alongside experienced leaders.

Essential Duties and Responsibilities

The main responsibilities of this role include:

  • 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.
Requirements
Education and Experience
  • BA/BS degree required, preferably in a scientific or related discipline; an advanced degree (MS, PhD) is a plus.
  • Minimum of 2 years of experience in the pharmaceutical, biotechnology, or CDMO industry, or in project management within a regulated industry.
  • Experience supporting cGMP manufacturing activities or CMC projects.
  • Exposure to IND or NDA submission activities.
Knowledge and Skills
  • Clear, concise written and verbal communication skills, including the ability to distill complex discussions into key messages, decisions, and actionable next steps.
  • Communicates accurate, timely information and raises schedule risks early, clearly, and transparently.
  • Demonstrates reliability and accountability and consistently follows through on commitments.
  • Acts with integrity, discretion, and sound judgment.
  • Balances priorities objectively across programs and teams, with a focus on overall program success.
  • Experience using project management and collaboration tools such as Microsoft Project, Smartsheet, or SharePoint is preferred.
  • Strong organizational skills and attention to detail.
VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. #LI-DNI

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