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Director, Drug Substance Development

South San Francisco, California, United States, Princeton, New Jersey, United States

About Us 

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.

It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
 
Led by Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
 
We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
 
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
 
These values are the foundation of our work, empowering us to make a real difference, every day.
 
 

Role Overview

Kardigan is seeking an experienced and accomplished Director  of CMC Drug Substance Development. Reporting directly to the VP of Chemical Development, this candidate will work with the other members of the Chem Dev department to oversee the development of a growing early‑stage pipeline and a complex late‑stage portfolio across small molecules and oligonucleotides.

This role will support the  end‑to‑end API development — from route design through commercial readiness across the portfolio of small molecule candidates, — and will provide technical, strategic, and operational leadership across all internal and outsourced development and manufacturing activities, ensuring deliverables are met.

 

Key Responsibilities

Chemical & Process Development

  • Technical expert and/or technical lead for programs. Ensuring programs move smoothly through development from early phase to late phase, file and launch.
  • Technical expert/lead for route selection, process optimization, scale‑up, technology transfer, validation, and manufacturing strategy for all drug substance programs.
  • Ensure processes are designed to meet quality, yield, cost, and scalability targets appropriate for each development stage.
  • Develop and manage phase‑appropriate plans for process development, manufacturing, and supply.
  • Oversee and provide technical governance for all CDMO/CMO‑executed activities.
  • Provide support and guidance to other members of the Tech Ops department

Quality, Regulatory & Technical Documentation, including

  • Batch release activities
  • Establish drug substance specifications and stability programs in partnership with Analytical, Quality, and Regulatory functions.
  • Author and review CMC documentation for regulatory submissions, including protocols, reports, and Module 3 sections.
  • Support investigations, deviations, and root‑cause analyses to ensure robust scientific and operational outcomes.
  • Lead technical trouble shooting activities and ensure appropriate technical solutions are implemented.

Cross‑Functional Collaboration

  • Partner closely with Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Supply Chain, and Legal to ensure aligned execution across the development lifecycle.
  • Support inspection readiness and interactions with global health authorities.
  • Work with Procurement and Legal teams to negotiate and manage contracts governing outsourced development and manufacturing.

Strategy, Planning & Risk Management

  • Maintain awareness of evolving regulatory expectations and state‑of‑the‑art manufacturing technologies.
  • Assess CDMO capacity, supply chain risks, and inventory vulnerabilities and present effective solutions to executive leadership.
  • Support strategic planning for drug substance sourcing, technology strategy, and long‑term capability development.
  • Oversee contract deliverables and ensure operational alignment with Kardigan’s business objectives.

 

Qualifications & Preferred Experience

  • BS and MS/PhD in Organic Chemistry, Chemical Engineering, or a related scientific discipline
  • 10+ years of experience in the development of assets, spanning early‑ and late‑stage development.
  • Expertise in small molecules and preferably oligonucleotide product development.
  • Experience in leading the development of mid Phase and late phase assets
  • Demonstrated experience taking drug substances from R&D through commercialization.
  • Strong knowledge of GMP, global regulatory expectations, and quality systems.
  • Direct experience with global regulatory submissions (IND, IMPD, NDA, MAA).
  • Proven leadership in process validation and continuous improvement initiatives.
  • Excellent communication and presentation skills, with the ability to partner effectively and work within cross‑functional teams.
  • Ability to operate with agility in a fast‑paced, matrixed, growth‑oriented environment.
  • Creative, solutions‑focused mindset with a track record of driving operational progress and scientific excellence.

 

 

Exact Compensation may vary based on skills, experience and location.

Pay range

$202,000 - $263,000 USD

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