Kardigan · 1 day ago
Director, Analytical Development
Princeton, NJ
Full-time
Onsite
Director/Executive
$199K/yr - $259K/yr
10+ years expKardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. They are seeking a strategic and hands-on analytical leader to join their Analytical Development team, responsible for leading analytical development for small molecules and/or oligonucleotide programs, collaborating across CMC functions, and ensuring timely analytical deliverables for product development.
Artificial Intelligence (AI)BiopharmaHealth CareMedical
Responsibilities
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
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)
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
Qualification
Required
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
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
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
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
Company
Kardigan
Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.
51-200 employees
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)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
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
Company data provided by crunchbase