Senior Director, Drug Substance Development

About Us 

Position Title: Senior Director Drug Substance Development

Department: Technical Operations

Reports To: VP Head of Drug Substance Development

About Us

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 Overview

Kardigan is seeking a Director position, to support development of a large late phase portfolio. This role will report directly to the VP of DS Development.

In this role, you will be responsible for the API development of Kardigan’s portfolio of medicines. Responsibilities include chemical route optimization, process development, manufacture and supply of drug substance; including the leadership, management and oversight of all outsourced chemical development, process development, scale-up, validation, technology transfer, and file launch activities required to support Kardigan’s portfolio of small molecules and oligonucleotides.  This role will include oversight and support management of 3^rd party CDMOs and CMOs. The role is accountable for leading successful drug substance process development and scale-up, technology transfer, registration and validation lots, authoring of Module 3 documents and working closely with CDMOs to support inspection readiness.  This is a 4-day, onsite position in Princeton NJ.

Essential Duties and Responsibilities

• Build and lead a highly performing, experienced Chemical Development group that can successfully support a growing portfolio of both early phase and multiple complex late phase assets.
• Manage and oversee final synthetic route development and optimization, process development, scale-up, validation, technology transfer, and clinical/commercial drug substance manufacturing to support multiple early and late Phase clinical development programs and future commercial supply.
• Ensure the development of each asset meets the requirements for route, process, yield, COG and quality to enable the successful commercialization of the products under development.
• Develop phase-appropriate pharmaceutical project plans, participate in CDMO selection, and manage successful execution of these plans consistent with corporate timelines and compliant with cGMP/regulatory requirements and expectations.
• Develop, review, and approve batch records, manage internal batch release activities.
• Establish appropriate drug substance specifications and stability studies in partnership with Analytical, Quality, CDMOs, Regulatory, and other subject matter experts to support intended use.
• Write and review protocols, reports, and drug substance t sections for regulatory documents.
• Contribute to product investigations and conduct root cause analysis.
• Interface and coordinate activities with drug products, analytical development, regulatory affairs, quality assurance, and product supply to ensure on time release and uninterrupted supply of drug substance.
• Keep up with the latest regulatory and cGMP guidance and awareness of state-of-the-art manufacturing practices.
• Monitor status of CDMO capacity, manage inventory risks and make recommendations to Kardigan’s executive leadership.

Qualifications and Preferred Skills

• S, MS or PhD in chemistry, chemical engineering, or related discipline. Advanced degree preferred.
• Minimum 15 years' experience within pharmaceutical CMC development and Technical Operations. Experience with both small molecule and oligonucleotide products is preferred.
• Sound knowledge of chemical development, process engineering and/or plant operations
• Demonstrated experience with drug substance process development, scale-up, technology transfer, and optimization from R&D through commercialization, including an understanding of the interdependencies of functional groups and working closely with external CDMOs.
• Significant experience in working with global health authorities, IND, IMPD, NDA, MAA etc
• Experience with process validation and continuous process improvement.
• Ideally experience with commercializing small molecules and oligonucleotide drug products
• Extensive knowledge of regulated manufacturing, GMP, GCP and quality systems.
• Creative/innovative/problem solver that actively drives progress.
• Ability to manage multiple projects in a fast-paced environment.
• Strong interpersonal communication skills, proven ability to build and maintain collaborative, effective internal and external relationships.
• Excellent written, oral communication, and presentation skills along with the ability to communicate effectively with executive-level management.
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.