Kardigan · 11 hours ago
VP, Head of Drug Substance Development
Princeton, NJ
Full-time
Hybrid
Director/Executive
$270K/yr - $372K/yr
15+ years expKardigan is a heart health company focused on making cardiovascular disease preventable and curable. They are seeking a Vice President, Head of CMC Drug Substance Development to lead and build a Chemical Development organization that supports their early-stage and late-stage pipeline.
Artificial Intelligence (AI)BiopharmaHealth CareMedical
Responsibilities
Provide strong, visible leadership to the Chemical Development function
Build, lead, mentor, and retain a high-performing team supporting programs from early development through commercialization
Oversee onboarding, career development, and capability building across the organization
Foster a culture of scientific excellence, accountability, and collaborative problem-solving
Build a culture within Chem Dev that collaborates well and works effectively with others
Support the ongoing development and growth of the Tech Ops capability within Kardigan, contribute effectively as a member of the Tech Ops LT
Lead 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
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
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
Lead 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
15+ years of experience in leading the development of assets, spanning early- and late-stage development
Expertise in small molecule and preferably oligonucleotide process 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 with executive leadership and 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
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
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