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Vp Cmc information

What is a VP CMC?

A VP CMC (Vice President of Chemistry, Manufacturing, and Controls) is a senior executive responsible for overseeing all aspects of drug development related to chemistry, manufacturing processes, and quality controls. This role typically exists in pharmaceutical or biotechnology companies and ensures that products are developed, manufactured, and controlled according to regulatory standards. The VP CMC collaborates with research, regulatory, and commercial teams to ensure efficient and compliant product development from early research through commercialization. They are also responsible for managing teams, budgets, and timelines to meet critical milestones.

What are the typical challenges a VP CMC faces when scaling up manufacturing for clinical trials and commercial launch?

A VP of CMC (Chemistry, Manufacturing, and Controls) often encounters challenges in scaling up manufacturing processes, including ensuring consistent product quality, meeting strict regulatory requirements, and managing timelines across multiple stakeholders. Coordinating between R&D, manufacturing, and quality teams is crucial to address technical hurdles and maintain compliance. Additionally, adapting to evolving regulations and managing supply chain complexities are key responsibilities, especially when progressing from clinical trials to commercial production.

What are the key skills and qualifications needed to thrive as a VP CMC, and why are they important?

To thrive as a VP CMC, you need deep expertise in pharmaceutical development, regulatory compliance, and process optimization, typically supported by an advanced degree in chemistry, chemical engineering, or a related field. Familiarity with regulatory submission systems, quality management platforms, and CMC documentation tools is essential. Leadership, strategic thinking, and excellent communication are critical soft skills for guiding cross-functional teams and aligning stakeholders. These skills ensure efficient drug development, regulatory approval, and successful product launches in a highly regulated industry.

What is the difference between Vp Cmc vs Regulatory Affairs Manager?

AspectVp CmcRegulatory Affairs Manager
CredentialsAdvanced degrees in life sciences, experience in CMC developmentBachelor's or Master's in life sciences, regulatory certifications
Work EnvironmentStrategic leadership in R&D and manufacturingRegulatory compliance, documentation, and submissions
Industry UsagePharmaceutical and biotech companies, overseeing CMC activitiesRegulatory agencies, pharmaceutical companies, ensuring compliance

The Vp Cmc focuses on overseeing chemistry, manufacturing, and controls (CMC) processes at a strategic level, ensuring product quality and compliance. Regulatory Affairs Managers handle regulatory submissions and compliance activities. While both roles require industry knowledge, Vp Cmc roles are more senior and strategic, whereas Regulatory Affairs Managers focus on regulatory documentation and compliance tasks.

What are popular job titles related to Vp Cmc jobs in Indiana?

For Vp Cmc jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Vp Cmc jobs in Indiana look for?

The top searched job categories for Vp Cmc jobs in Indiana are:

Vp Cmc jobs near you
Infographic showing various Vp Cmc job openings in Indiana as of August 2026, with employment types broken down into 92% Full Time, 6% Part Time, and 2% Contract. Highlights an 82% Physical, 5% Hybrid, and 13% Remote job distribution.

Associate Director, CMC Project Management

Initial Therapeutics, Inc.

Indianapolis, IN • On-site

$115.50 - $169.40/hr

Other

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Summary

The Associate Director, CMC Project Management will provide strategic and operational leadership for cross‑functional CMC team(s) and will partner with CMC scientific and technical leaders with accountability for technical deliverables. CMC Project Management is the program and project management arm of our critical Product Research and Development group. CMC Project Managers are responsible for leading the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch.

Responsibilities
  • Effectively partner with global program team/governance and translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross‑functional CMC teams for programs of moderate complexity. Lead the creation, development, communication and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch. Leverage portfolio knowledge and development/financial acumen to enable investment strategy optimization at both project and portfolio level. The Associate Director, CMC Project Management may also partner with the Senior Director or Assoc. VP, CMC Project Management to deliver high complexity programs.
  • Drive cross‑functional CMC teams to maximize the value of data, create bold/competitive plans, anticipate risks, effectively communicate risks, enable high quality decisions at fast speed and implement decisions.
  • Know when and how to appropriately raise issues to team and to stakeholders. Keep both team members and stakeholders fully apprised of project status and issues at the right level of detail.
  • Leverage AI tools and emerging technologies to streamline CMC project planning, accelerate cross‑functional decision‑making, and drive continuous improvement in team productivity.
  • Develop high performing matrix teams with an ability to quickly identify gaps in team effectiveness and implement remediation efforts to ensure project success.
  • Support Due Diligence efforts by leading CMC plan development and integrating/communicating key findings with LRL/BU/M&Q stakeholders.
  • Participate in or lead continuous improvement projects, which can significantly impact the work and/or effectiveness of CMC development. These projects can be cross divisional and relate to optimizing capabilities, systems, and processes for divisions and/or portfolio.
Basic Requirements
  • BS degree in a scientific or engineering discipline (e.g., chemistry, biochemistry, chemical engineering, pharmaceutical sciences, biology, or related field).
  • 5+ years of drug development experience and good understanding of the different phases of development, associated CMC deliverables, and how the various functional areas contribute to a comprehensive strategy.
  • Demonstrated ability to lead cross‑functional team(s) and together solve complex problems.
  • Demonstrated ability to rapidly become proficient in new tools.
  • Demonstrated ability to communicate complex issues timely, precisely, and succinctly.
Preferred Education/Experiences
  • Advanced degree (Master of Science, Master of Business Administration, PharmD, Ph.D.).
  • Global submissions/approvals experiences.
  • Supervisory experiences.
  • Practical experience (formal or informal) in project management of cross‑functional projects.
  • Project Management Professional (PMP) Certification.

If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form https://careers.lilly.com/us/en/workplace-accommodation for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $169,400.

Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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