About Us
Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. Kardigan’s mission is to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by co-founders Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigan has a history of discovery and development in cardiovascular medicine. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team focused on improving patient lives. These values guide how we work and interact, emphasizing patient-centricity, authenticity, curiosity, teamwork, and the willingness to enable the impossible to unlock innovation for patients. About the Role Kardigan Bio is seeking a strategic and hands-on analytical leader to join our Analytical Development team within Technical Operations. In this role, you will lead analytical development for small molecules and/or oligonucleotide programs, supporting late-phase development through regulatory submission and commercial launch. You will collaborate across CMC functions and with external partners to ensure robust, compliant, and timely analytical deliverables that enable successful product development and lifecycle management. This position reports to the Vice President of Analytical Development and offers a unique opportunity to shape analytical strategy in a fast-paced, science-driven environment. It is a 4-day onsite position M-Th. Key Responsibilities
Analytical Leadership & Strategy Lead analytical development activities across drug substance and drug product programs by leveraging a global network of CDMOs. Develop and implement phase-appropriate analytical methods, specifications, and validation strategies aligned with project goals and regulatory expectations. Drive analytical deliverables with scientific rigor in a timely manner to meet development timelines and quality standards. Cross-Functional Collaboration Partner with Drug Substance and Drug Product Development teams to influence CDMO execution and ensure alignment with CMC strategy. Work closely with CMC Quality, QC, and Stability Operations to support batch release and stability testing for clinical and commercial materials. Collaborate with CMC Regulatory to author and review analytical sections of regulatory submissions (IND, IMPD, NDA). External Partner Management Support due diligence and selection of CDMOs, ensuring technical capabilities and alignment with project needs. Oversee outsourced analytical activities, ensuring execution within budget and timelines while maintaining high scientific and compliance standards. Qualifications
Education & Experience PhD in Chemistry or related discipline with 10+ years of pharmaceutical industry experience, or MS/BS with additionally relevant pharmaceutical industry experience. Proven track record in analytical development for small molecules and/or oligonucleotides, including authoring regulatory file to support late-phase and commercial programs. Technical Expertise Deep knowledge of analytical techniques, instrumentation, and method development/validation across development stages. Strong understanding of cGMP, ICH guidelines, and global regulatory requirements. Comprehensive knowledge of process characterization, and CMC control strategy development. Experience supporting or leading GMP audits and inspections. Leadership & Communication Demonstrated ability to lead analytical projects and contribute to CMC regulatory strategy. Excellent verbal and written communication skills, with the ability to influence internal and external stakeholders. Strong organizational skills, with a proactive and solution-oriented mindset. Agility Comfortable navigating technical complexity and ambiguity. Passionate about implementing science-based strategies to problem solving, focused on regulatory compliance and quality, and delivering impactful therapies to patients. Thrives in a dynamic, challenging environment. Exact compensation may vary based on skills, experience and location. Pay range: $199,000 - $259,000 USD
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Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. Kardigan’s mission is to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by co-founders Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigan has a history of discovery and development in cardiovascular medicine. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team focused on improving patient lives. These values guide how we work and interact, emphasizing patient-centricity, authenticity, curiosity, teamwork, and the willingness to enable the impossible to unlock innovation for patients. About the Role Kardigan Bio is seeking a strategic and hands-on analytical leader to join our Analytical Development team within Technical Operations. In this role, you will lead analytical development for small molecules and/or oligonucleotide programs, supporting late-phase development through regulatory submission and commercial launch. You will collaborate across CMC functions and with external partners to ensure robust, compliant, and timely analytical deliverables that enable successful product development and lifecycle management. This position reports to the Vice President of Analytical Development and offers a unique opportunity to shape analytical strategy in a fast-paced, science-driven environment. It is a 4-day onsite position M-Th. Key Responsibilities
Analytical Leadership & Strategy Lead analytical development activities across drug substance and drug product programs by leveraging a global network of CDMOs. Develop and implement phase-appropriate analytical methods, specifications, and validation strategies aligned with project goals and regulatory expectations. Drive analytical deliverables with scientific rigor in a timely manner to meet development timelines and quality standards. Cross-Functional Collaboration Partner with Drug Substance and Drug Product Development teams to influence CDMO execution and ensure alignment with CMC strategy. Work closely with CMC Quality, QC, and Stability Operations to support batch release and stability testing for clinical and commercial materials. Collaborate with CMC Regulatory to author and review analytical sections of regulatory submissions (IND, IMPD, NDA). External Partner Management Support due diligence and selection of CDMOs, ensuring technical capabilities and alignment with project needs. Oversee outsourced analytical activities, ensuring execution within budget and timelines while maintaining high scientific and compliance standards. Qualifications
Education & Experience PhD in Chemistry or related discipline with 10+ years of pharmaceutical industry experience, or MS/BS with additionally relevant pharmaceutical industry experience. Proven track record in analytical development for small molecules and/or oligonucleotides, including authoring regulatory file to support late-phase and commercial programs. Technical Expertise Deep knowledge of analytical techniques, instrumentation, and method development/validation across development stages. Strong understanding of cGMP, ICH guidelines, and global regulatory requirements. Comprehensive knowledge of process characterization, and CMC control strategy development. Experience supporting or leading GMP audits and inspections. Leadership & Communication Demonstrated ability to lead analytical projects and contribute to CMC regulatory strategy. Excellent verbal and written communication skills, with the ability to influence internal and external stakeholders. Strong organizational skills, with a proactive and solution-oriented mindset. Agility Comfortable navigating technical complexity and ambiguity. Passionate about implementing science-based strategies to problem solving, focused on regulatory compliance and quality, and delivering impactful therapies to patients. Thrives in a dynamic, challenging environment. Exact compensation may vary based on skills, experience and location. Pay range: $199,000 - $259,000 USD
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