Sr. Director, Drug Substance Development

Kardigan•Princeton, NJ

7h•$241,000 - $314,000•Onsite

About The Position

Kardigan is seeking an experienced and accomplished Senior Director of CMC Drug Substance Development. Reporting directly to the VP of Chemical Development, this candidate will oversee the development of a growing early‑stage pipeline and a complex late‑stage portfolio across small molecules and oligonucleotides. This role is responsible for ensuring the end‑to-end API development — from route design through commercial readiness across the portfolio of small molecule candidates, — and for providing technical, strategic, and operational leadership across all internal and outsourced development and manufacturing activities, ensuring deliverables are met.

Requirements

BS and MS/PhD in Organic Chemistry, Chemical Engineering, or a related scientific discipline
15+ years of experience in the development of assets, spanning early‑ and late‑stage development.
Expertise in small molecule 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.

Responsibilities

Technical lead for programs. Ensuring programs move smoothly through development from early phase to late phase, file and launch.
Technical 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
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.
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.
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.