Kardigan
Overview
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. The co-founders led the development of mavacamten, the first cardiac myosin inhibitor, and the company is focused on an industry-leading research platform and a pipeline of late-stage candidates. At Kardigan, we are guided by values that prioritize patients, authenticity, curiosity, teamwork, and bold innovation to enable the impossible for patients. We are committed to creating an inclusive environment where every person is welcomed and empowered to contribute. Position and Team
Position Title:
Associate Director, Drug Substance Development (Director-level candidates welcome to apply) Department:
Technical Operations - Drug Substance Reports To:
Vice President, Head of Drug Substance Location:
Princeton, NJ – On-site 4 days per week (Mon to Thurs) Job Overview
Kardigan Bio is looking for an Associate Director/Director to join the Drug Substance team within the Technical Operations department. The role is responsible for implementing oligonucleotide and small molecule manufacturing technologies, collaborating across departments to ensure facility fit, developing process documentation (global guidance documents, process control strategies, risk assessments, inspection readiness, and technical regulatory submissions). The role supports clinical and commercial product lifecycle management, including authoring technical assessments and monitoring process performance (e.g., continued process verification). The position collaborates across all CMC functional areas to ensure project advancement and rapid, best-in-class execution. Essential Duties and Responsibilities
Lead process and technology transfers, change management, and provide technical process support for clinical and commercial oligonucleotide and small molecule products. Own process control strategies including process risk assessments and process validation. Analyze data using historical process experience and characterization studies to identify trends and drive changes in process control strategy and risk assessments. Lead production-related investigations in compliance with internal standards and regulatory requirements. Own process validation (PV) reports and monitor manufacturing processes to understand capability and performance drift over time. Provide technical analyses to support impact assessments and investigations. Develop, execute and implement manufacturing process improvement activities in line with the product life cycle plan. Share operational and process learnings with the manufacturing network. Basic Qualifications
MSc or BSc in Chemistry or equivalent with 15+ years of relevant experience. Familiarity with oligonucleotide/small molecule processes and cGMPs is preferred. Ability to effectively lead cross-functional teams, meet deadlines, and prioritize responsibilities. Ability to assess risk and develop contingency plans for process risks. Experienced with small molecule and oligonucleotide drug substance programs. Experience with purification and drying unit operations for oligonucleotide products, filtration, ultrafiltration and chromatography technologies. Authored technical reports, application notes, risk assessments, and protocols. Experience managing relationships with external partners to drive business objectives. Experience with Regulatory IND and NDA submissions. Experience designing and deploying standard work tools for data collection and interpretation, and advanced data management and statistical analysis. Experience working in a self-driven, performance/results oriented, fast-paced matrix environment. Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. Strong time management and ability to elevate issues to project lead and line management. Detail oriented with strong verbal and written communication skills. Strong interpersonal and leadership skills to work with teams in different functions and organizations including CDMOs. Qualifications and Preferred Skills
Experience with oligonucleotide/small molecule process characterization, control strategy, development and/or manufacturing. Experience with NDA submissions for oligonucleotide and small molecule programs. Experience with technology transfer in a manufacturing environment and process validation (PIP) support. Proficiency with MS Office and working knowledge of JMP, Spotfire, Minitab. 10-15 years of experience in oligonucleotide or small molecule process development, MS&T, and/or manufacturing. Experience with commercial product support, post-marketing commitments, ongoing validation and comparability. Equal Opportunity
We are an equal opportunity employer. Voluntary self-identification of disability and veteran status information is collected for government reporting purposes. Participation is voluntary and will not affect hiring decisions. See the notice and forms provided with the application for more information.
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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. The co-founders led the development of mavacamten, the first cardiac myosin inhibitor, and the company is focused on an industry-leading research platform and a pipeline of late-stage candidates. At Kardigan, we are guided by values that prioritize patients, authenticity, curiosity, teamwork, and bold innovation to enable the impossible for patients. We are committed to creating an inclusive environment where every person is welcomed and empowered to contribute. Position and Team
Position Title:
Associate Director, Drug Substance Development (Director-level candidates welcome to apply) Department:
Technical Operations - Drug Substance Reports To:
Vice President, Head of Drug Substance Location:
Princeton, NJ – On-site 4 days per week (Mon to Thurs) Job Overview
Kardigan Bio is looking for an Associate Director/Director to join the Drug Substance team within the Technical Operations department. The role is responsible for implementing oligonucleotide and small molecule manufacturing technologies, collaborating across departments to ensure facility fit, developing process documentation (global guidance documents, process control strategies, risk assessments, inspection readiness, and technical regulatory submissions). The role supports clinical and commercial product lifecycle management, including authoring technical assessments and monitoring process performance (e.g., continued process verification). The position collaborates across all CMC functional areas to ensure project advancement and rapid, best-in-class execution. Essential Duties and Responsibilities
Lead process and technology transfers, change management, and provide technical process support for clinical and commercial oligonucleotide and small molecule products. Own process control strategies including process risk assessments and process validation. Analyze data using historical process experience and characterization studies to identify trends and drive changes in process control strategy and risk assessments. Lead production-related investigations in compliance with internal standards and regulatory requirements. Own process validation (PV) reports and monitor manufacturing processes to understand capability and performance drift over time. Provide technical analyses to support impact assessments and investigations. Develop, execute and implement manufacturing process improvement activities in line with the product life cycle plan. Share operational and process learnings with the manufacturing network. Basic Qualifications
MSc or BSc in Chemistry or equivalent with 15+ years of relevant experience. Familiarity with oligonucleotide/small molecule processes and cGMPs is preferred. Ability to effectively lead cross-functional teams, meet deadlines, and prioritize responsibilities. Ability to assess risk and develop contingency plans for process risks. Experienced with small molecule and oligonucleotide drug substance programs. Experience with purification and drying unit operations for oligonucleotide products, filtration, ultrafiltration and chromatography technologies. Authored technical reports, application notes, risk assessments, and protocols. Experience managing relationships with external partners to drive business objectives. Experience with Regulatory IND and NDA submissions. Experience designing and deploying standard work tools for data collection and interpretation, and advanced data management and statistical analysis. Experience working in a self-driven, performance/results oriented, fast-paced matrix environment. Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. Strong time management and ability to elevate issues to project lead and line management. Detail oriented with strong verbal and written communication skills. Strong interpersonal and leadership skills to work with teams in different functions and organizations including CDMOs. Qualifications and Preferred Skills
Experience with oligonucleotide/small molecule process characterization, control strategy, development and/or manufacturing. Experience with NDA submissions for oligonucleotide and small molecule programs. Experience with technology transfer in a manufacturing environment and process validation (PIP) support. Proficiency with MS Office and working knowledge of JMP, Spotfire, Minitab. 10-15 years of experience in oligonucleotide or small molecule process development, MS&T, and/or manufacturing. Experience with commercial product support, post-marketing commitments, ongoing validation and comparability. Equal Opportunity
We are an equal opportunity employer. Voluntary self-identification of disability and veteran status information is collected for government reporting purposes. Participation is voluntary and will not affect hiring decisions. See the notice and forms provided with the application for more information.
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