Kardigan
Senior Director, Drug Substance Development
Kardigan is a heart health company committed to making cardiovascular disease preventable and curable. The mission is to develop targeted treatments for cardiovascular diseases to bring patients the cures they deserve. Led by founders Tassos Giannakakos, Jay Edelberg, M.D., and Bob McDowell, Ph.D., Kardigan has a cutting‑edge discovery platform, a pipeline of late‑stage candidates, and an industry‑leading team.
We value patients, authenticity, learning, teamwork, and innovation. These values guide how we work and enable us to make real differences.
Department:
Technical Operations Reports To:
VP Head of DS Development
Job Overview Senior Director to support development of a large late‑phase portfolio leading to an NDA. This role reports to the VP of DS Development and will oversee API development of Kardigan’s portfolio of medicines. Responsibilities include chemical route optimization, process development, manufacturing, scale‑up, validation, technology transfer, and regulatory file launch. Leadership over outsourced chemical development and CDMOs/CMOs is required. The position is onsite 4 days a week in Princeton, NJ.
Essential Duties and Responsibilities
Build and lead a high‑performing Chemical Development group supporting early and late‑phase assets.
Oversee final synthetic route development, process development, scale‑up, validation, technology transfer, and commercial drug substance manufacturing.
Ensure each asset meets synthetic route, process, yield, and quality requirements for successful validation and commercialization.
Develop phase‑appropriate project plans, manage CDMO selection, and execute plans in line with corporate timelines and cGMP/regulatory requirements.
Apply risk‑assessment tools to control impurities and comply with ICH guidelines.
Approve batch records, manage internal releases, and establish drug substance specifications and stability studies in partnership with Analytical, Quality, CDMOs, and Regulatory experts.
Write and review protocols, reports, and drug substance sections for regulatory documents.
Contribute to product investigations and root‑cause analysis.
Coordinate with drug products, analytical development, regulatory affairs, QA, and product supply for on‑time release and uninterrupted supply.
Stay current on regulatory and cGMP guidance and advanced manufacturing practices.
Monitor CDMO capacity, manage inventory risks, and advise executive leadership.
Qualifications and Preferred Skills
Advanced degree (Bachelor, MS, or PhD) in organic chemistry or related discipline.
Minimum 15 years in pharmaceutical CMC development and Technical Operations, with experience in small‑molecule and oligonucleotide products.
Sound knowledge of chemical development, process engineering, and plant operations.
Experience in drug substance development, scale‑up, technology transfer, and optimization from R&D to commercialization.
Involvement in NDA submission for oligonucleotide or small‑molecule programs.
Experience working with global health authorities (IND, IMPD, NDA, MAA).
Experience in process validation and continuous improvement.
Experience commercializing small molecules and oligonucleotide drug substances.
Extensive knowledge of GMP, GCP, and quality systems.
Creative, innovative problem‑solver who drives progress.
Ability to manage multiple projects in a fast‑paced environment.
Strong interpersonal and written communication skills, including executive‑level presentation ability.
Collaborative in a cross‑functional matrix environment.
Compensation Exact compensation may vary based on skills, experience, and location.
Pay range:
$229,000 – $298,000 USD
Equal Employment Opportunity As set forth in Kardigan’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
Voluntary Self‑Identification For government reporting, we ask candidates to voluntarily complete a self‑identification survey. Completion is optional and will not be used in the hiring process.
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We value patients, authenticity, learning, teamwork, and innovation. These values guide how we work and enable us to make real differences.
Department:
Technical Operations Reports To:
VP Head of DS Development
Job Overview Senior Director to support development of a large late‑phase portfolio leading to an NDA. This role reports to the VP of DS Development and will oversee API development of Kardigan’s portfolio of medicines. Responsibilities include chemical route optimization, process development, manufacturing, scale‑up, validation, technology transfer, and regulatory file launch. Leadership over outsourced chemical development and CDMOs/CMOs is required. The position is onsite 4 days a week in Princeton, NJ.
Essential Duties and Responsibilities
Build and lead a high‑performing Chemical Development group supporting early and late‑phase assets.
Oversee final synthetic route development, process development, scale‑up, validation, technology transfer, and commercial drug substance manufacturing.
Ensure each asset meets synthetic route, process, yield, and quality requirements for successful validation and commercialization.
Develop phase‑appropriate project plans, manage CDMO selection, and execute plans in line with corporate timelines and cGMP/regulatory requirements.
Apply risk‑assessment tools to control impurities and comply with ICH guidelines.
Approve batch records, manage internal releases, and establish drug substance specifications and stability studies in partnership with Analytical, Quality, CDMOs, and Regulatory experts.
Write and review protocols, reports, and drug substance sections for regulatory documents.
Contribute to product investigations and root‑cause analysis.
Coordinate with drug products, analytical development, regulatory affairs, QA, and product supply for on‑time release and uninterrupted supply.
Stay current on regulatory and cGMP guidance and advanced manufacturing practices.
Monitor CDMO capacity, manage inventory risks, and advise executive leadership.
Qualifications and Preferred Skills
Advanced degree (Bachelor, MS, or PhD) in organic chemistry or related discipline.
Minimum 15 years in pharmaceutical CMC development and Technical Operations, with experience in small‑molecule and oligonucleotide products.
Sound knowledge of chemical development, process engineering, and plant operations.
Experience in drug substance development, scale‑up, technology transfer, and optimization from R&D to commercialization.
Involvement in NDA submission for oligonucleotide or small‑molecule programs.
Experience working with global health authorities (IND, IMPD, NDA, MAA).
Experience in process validation and continuous improvement.
Experience commercializing small molecules and oligonucleotide drug substances.
Extensive knowledge of GMP, GCP, and quality systems.
Creative, innovative problem‑solver who drives progress.
Ability to manage multiple projects in a fast‑paced environment.
Strong interpersonal and written communication skills, including executive‑level presentation ability.
Collaborative in a cross‑functional matrix environment.
Compensation Exact compensation may vary based on skills, experience, and location.
Pay range:
$229,000 – $298,000 USD
Equal Employment Opportunity As set forth in Kardigan’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
Voluntary Self‑Identification For government reporting, we ask candidates to voluntarily complete a self‑identification survey. Completion is optional and will not be used in the hiring process.
#J-18808-Ljbffr