Associate Director, Analytical Development

Kardigan•Princeton, NJ

1d•$180,000 - $234,000•Onsite

About The Position

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).

Requirements

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

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