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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 Gianakakos, Jay Edelberg, M.D., Ph.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.
 
 

Job Description: 

Kardigan Bio is seeking an Associate Director, Analytical Development.  In this role, you will lead analytical development for small molecules and oligonucleotides, supporting projects through regulatory registration 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 is a 4 day on-site position (M-TH)

Key responsibilities:

  • Drive with pace to ensure internal alignment of analytical development strategy and analytical deliverable timelines
  • Collaborate with Drug Substance Development, Drug Product Development, CMC Quality, and CMC Regulatory to ensure stability and analytical testing to align with CMC Development and CMC Regulatory strategy
  • Collaborate with CMC Regulatory to author analytical sections of the CMC module to support IND, IMPD, and NDA
  • Independently lead analytical development through CDMOs to ensure appropriate analytical methods, specifications, and stability study protocols are implemented to deliver CMC objectives
  • Oversee cGMP testing to ensure experiments are created and documented to comply with quality requirements including compliance with data integrity regulations
  • Manage deviation and change control by following internal and external procedures. Support troubleshooting and laboratory investigation for root cause identification, and to approve investigation plan and CAPAs in collaboration with CMC Quality if necessary
  • Collaborate with CMC Quality and QC/Stability Operations to manage batch release and stability testing to support on time release of GLP tox, and clinical drug substance and drug product supplies
  • Provide DS retest and DP shelf-life justification to support CMC Quality and QC for release of clinical DS and DP
  • Oversee analytical characterization and CDMO inventory monitoring of reference standards and reference materials
  • Support due diligent activities for CDMO selection and management, including planning and reviewing technical execution to ensure analytical deliverables are conducted within budgets and timelines  

Qualifications: 

  • PhD in Chemistry or related disciplines with a minimum 8 years of experience in pharmaceutical industry, or MS/BS with additional industry experience  
  • Strong knowledge in analytical techniques, instrumentation, and phase appropriate analytical method development and validation
  • Expertise in cGMP and Regulatory guidelines, and experience supporting or fronting GMP audit or inspection
  • Demonstrated analytical project leadership including recommendation for regulatory filing strategy and development of CMC control strategy 
  • Desire to work in a fast-paced, dynamic environment with ability to navigate through technical complexities
  • Excellent verbal and written communication, organization, and planning skills

 

Exact Compensation may vary based on skills, experience and location.

Pay range

$180,000 - $234,000 USD

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