Director, Analytical Development
About The Position
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/or 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. Onsite 4 days M-Th
Requirements
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
