Senior Director, Drug Product Development

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 our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. 

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.  

Position Title: Sr. Director, Drug Product Development

Department: Technical Operations

Reports To: VP, Drug Product 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 Senior Director, CMC Drug Product Development, to support development of late phase projects. This role will report directly into the Head of Drug Product Development.

In this role, you will be responsible for the leadership, management and oversight of outsourced formulation development, process development, scale-up, validation, technology transfer, and file launch activities required to support Kardigan’s portfolio of small molecules and oligonucleotides.  This hands-on role will lead drug product development, scale-up, technology transfer, registration and validation batches, authoring of Module 3 documents and working closely with CDMOs to support inspection readiness.  This is a 4-day, onsite position, based in Princeton NJ. (or South San Fransicso)

Essential Duties and Responsibilities

• Lead drug product development for both early phase and late phase assets.
• Lead or a member of CMC project teams accountable for all CMC activities to support both early and late phase projects.
• Manage and oversee outsourced formulation development, process development, scale-up, validation, technology transfer, and clinical/commercial drug product manufacturing to support early and late Phase clinical development programs and future commercial supply.
• Ensure formulation and drug products meet the target product profile necessary to enable the successful commercialization of the product.
• 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 manufacturing batch records, manage internal batch release activities.
• Establish appropriate drug product 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 product sections for regulatory documents.
• Contribute to product investigations and conduct root cause analysis.
• Interface and coordinate activities with drug substance, analytical development, regulatory affairs, quality assurance, and product supply to ensure on time release and uninterrupted supply of drug product.
• Collaborate with legal and procurement to review contract terms and execution of agreements.
• Keep up with the latest regulatory and cGMP guidance and awareness of state-of-the-art manufacturing practices.
• Monitor status of CDMO capacity, manage risks and make recommendations to Kardigan’s leadership team.
• Manage the negotiation of contracts broadly applicable to drug product manufacturing. Ownership of the contract deliverables and obligations.

Qualifications and Preferred Skills

• S. or PhD in pharmaceutical sciences, engineering, or related discipline. Advanced degree preferred.
• Minimum 15 years' experience within pharmaceutical CMC development and Technical Operations. Experience with both sterile and oral products, including device development is preferred
• Sound knowledge of formulation development, process engineering and plant operations
• Demonstrated experience with drug product process development, scale-up, 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 molecule 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 senior management.
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.