Head of External Manufacturing and Supply

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: Head of External Manufacturing and Supply

Department: Technical Operations

Reports To: Chief Technical Operations Officer

Job Overview

Kardigan is seeking a VP Head, External Manufacturing and Supply, to support development of a large late phase portfolio. This role will report directly into the Chief Technical Operations Officer.                                         In this role, you will be responsible for the leadership, management and oversight of all outsourced manufacturing activities required to support Kardigan’s portfolio of small molecules and oligonucleotides. This hands-on role will work closely with clinical, clinical supply, finance, quality, and manufacturing to develop forecast and production schedules. This role will also coordinate and manage relationships with CMOs, and supply vendors to ensure timely and quality production and distribution of clinical and commercial products. You will put in place contracts, secure manufacturing slots as required with each supplier, and work closely with the Heads of Development and the Head of clinical supply to build supply chains that meet the needs of both development activities and clinical and commercial supply.    The scope will include both drug substance manufacture, drug product manufacture, all supporting activities, for example milling and micronizing of drug substance, and packaging and labelling of clinical supplies. This hands-on role will develop and lead the External Manufacturing Group and put in place the supply chain required to support the clinical and commercial requirements of the Kardigan's portfolio.   This is ideally a 4-day, onsite position, based in South San Francisco or Princeton NJ, but can be remote, with a requirement to travel as required to the Companies offices in South San Francisco and Princeton NJ. 

Essential Duties and Responsibilities:

• Build and lead a high performing, experienced, external manufacturing group that can successfully support a growing portfolio of both early phase, and also multiple complex late phase assets.
• Manage and oversee outsourced clinical/commercial drug product manufacturing to support multiple early and late Phase clinical development programs and future commercial supply.
• Establish clinical and commercial supply plans to satisfy demand forecasts for clinical drug supplies for global studies and commercial launch including demand/supply/capacity planning, sourcing, labeling, packaging, inventory management, cold chain shipping, import/export and distribution.
• Manage cohesive relationships with CMOs and secondary packaging vendors for timely production and quality releases for on-time delivery.
• Manage inventory of bulk, packaging components, chemicals and finished commercial goods at contract warehouses and vendors resulting in optimal supply chain operations.
• Oversee inventory, ensure that sufficient inventory is maintained to ensure clinical and commercial supply do not risk stock out.
• Interface and coordinate activities with drug substance, drug product, analytical development, regulatory affairs, quality assurance, and clinical supply to ensure on time release and uninterrupted supply.
• Collaborate with legal and procurement and technical groups to review contract terms and execution of agreements.
• Monitor status of CDMO capacity, manage risks and make recommendations to Kardigan’s executive leadership.
• Development and oversight of the Technical Operations budget.
• Manage the negotiation of contracts broadly applicable to drug substance and drug product manufacturing. Ownership of the contract deliverables and obligations.
• Leads the development of Kardigan’s external manufacturing team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
• Attract, develop and grow key talent.
• Represent supply chain on cross-functional team meetings. Work collaboratively in a diverse, team-oriented environment and develop strong, cooperative working relationships with people at all levels of the organization and external partners and vendors.
• Lead the development of Kardigan’s supply chain team, including overseeing new employee onboarding and providing career development planning and learning opportunities. Develop and grow key talent

Qualifications and Preferred Skills:

• B.A. or B.S. or equivalent, experience in supply chain, shipping and/or logistics. MBA preferred as additional qualification.
• Minimum 12+ years of experience in the Biotechnology or Pharmaceutical industry.  
• Demonstrated leadership and technical experience as well as a proven track record of successful management of clinical and commercial supply, including product launch. 
• Demonstrated success having built a supply chain function in support of a fast-growing company.  
• 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 effectively in a dynamic, cross-functional matrix environment.  
• 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.
• Experience with building and managing budgets for a large organization is preferred.