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Kardigan · 23 hours ago

Senior Director, Drug Substance Development

Princeton, NJ

Full-time

Onsite

Director/Executive

$229K/yr - $298K/yr

15+ years exp

Kardigan is a heart health company focused on making cardiovascular disease preventable and curable. They are seeking a Senior Director to oversee the API development of their portfolio, managing chemical development, process optimization, and ensuring compliance with regulatory requirements.

Artificial Intelligence (AI)BiopharmaHealth CareMedical

H1B Sponsor Likely

Responsibilities

Build and lead a highly performing, experienced Chemical Development group that can successfully support a growing portfolio of both early phase and multiple complex late phase assets

Manage and oversee final synthetic route development and optimization, process development, scale-up, validation, technology transfer, and clinical/commercial drug substance manufacturing to support multiple late Phase clinical development programs and future commercial supply

Ensure the chemical development of each asset meets the requirements for synthetic chemical route, process, yield and quality to enable the successful process validation and commercialization of the products under development

Develop phase-appropriate pharmaceutical project plans, participate in CDMO selection, and manage successful execution of these plans consistent with corporate timelines and compliant with cGMP/regulatory requirements and expectations

Knowledge and management of risk assessment tools to control impurities and ensure compliance with ICH guidelines

Develop, review, and approve batch records, manage internal batch release activities

Establish appropriate drug substance specifications and stability studies in partnership with Analytical, Quality, CDMOs, Regulatory, and other subject matter experts to support intended use

Write and review protocols, reports, and drug substance sections for regulatory documents

Contribute to product investigations and conduct root cause analysis

Interface and coordinate scientific activities with drug products, analytical development, regulatory affairs, quality assurance, and product supply to ensure on time release and uninterrupted supply of drug substance

Keep up with the latest regulatory and cGMP guidance and awareness of state-of-the-art manufacturing practices

Monitor status of CDMO capacity, manage inventory risks and make recommendations to Kardigan’s executive leadership

Qualification

Organic ChemistryPharmaceutical CMC DevelopmentProcess DevelopmentTechnology TransferRegulatory ComplianceGMP KnowledgeProject ManagementInterpersonal CommunicationProblem SolvingCollaborationWritten CommunicationPresentation Skills

Required

BS, MS or PhD in organic chemistry, or related discipline

Minimum 15 years' experience within pharmaceutical CMC development and Technical Operations (additional development and commercial experience)

Sound knowledge of chemical development, process engineering and/or plant operations

Demonstrated experience with drug substance chemical development, scale-up, technology transfer, and optimization from R&D through commercialization, including an understanding of the interdependencies of functional groups and working closely with external CDMOs

Significant experience in working with global health authorities, IND, IMPD, NDA, MAA etc

Experience with process validation and continuous process improvement

Extensive knowledge of regulated manufacturing, GMP, GCP and quality systems

Creative/innovative/problem solver that actively drives progress

Ability to manage multiple projects in a fast-paced environment

Strong interpersonal communication skills, proven ability to build and maintain collaborative, effective internal and external relationships

Excellent written, oral communication, and presentation skills along with the ability to communicate effectively with executive-level management

Ability to effectively collaborate in a dynamic, cross-functional matrix environment

Preferred

Advanced degree preferred

Experience with both small molecule and oligonucleotide products is preferred

Supported NDA submission for oligonucleotide, and/or small molecule programs

Ideally experience commercializing small molecules and oligonucleotide drug substance

Company

Kardigan

Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.

Founded in 2023

South San Francisco, California, USA

51-200 employees

https://www.kardigan.bio

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)

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Trends of Total Sponsorships

2025 (1)