Associate Director, Analytical Development presso Kardigan

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.