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Associate Director, Analytical Development

Princeton, New Jersey, United States

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.

It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
 
Led by Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
 
We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
 
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
 
These values are the foundation of our work, empowering us to make a real difference, every day.
 
 

Position Title: Associate Director, Analytical Development (Director-level candidates welcome to apply)

Department: Analytical Development - Technical Operations

Reports To: VP, Head of Analytical Development

Location: Princeton, NJ – On-site 4 days per week (Mon to Thurs) 

 

Job Overview 

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 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.

 

Essential Duties and Responsibilities 

Analytical Leadership & Strategy

  • Lead analytical development activities across drug substance and drug product programs, 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 and 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 and Preferred Skills 

Education & Experience

  • PhD in Chemistry or related discipline with 8+ 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 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 how to integrate analytical controls to the overarching CMC control strategy.
  • Experience supporting or leading GMP audits and inspections.

Leadership & Communication

  • Demonstrated ability to lead cross-functional 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.

Work Style

  • 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.

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