Kardigan · 21 hours ago
Director, Drug Substance Development
Princeton, NJ
Full-time
Onsite
Director/Executive
$202K/yr - $263K/yr
10+ years expKardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The Director of Drug Substance Development will oversee the development of early-stage and complex late-stage portfolios, providing technical and operational leadership across internal and outsourced activities.
Artificial Intelligence (AI)BiopharmaHealth CareMedical
Responsibilities
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
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
Qualification
Required
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
Company
Kardigan
Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.
51-200 employees
H1B Sponsorship
Kardigan has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Growth StageTotal Funding
$554M2025-10-14Series B· $254M
2025-01-10Series A· $300M
Leadership Team
Brianne Jahn
Chief Financial Officer
Diane Hagerty
Chief Quality Officer
Recent News
2025-12-16
2025-11-19
Company data provided by crunchbase