Director, External Manufacturing

Job Overview

Kardigan is seeking a Director, External Manufacturing, to support development of a large late phase portfolio. This role will report directly to the Sr. Director of External Manufacturing. 

In this role, you will be responsible for management and oversight of Kardigan’s network of Contract Development & Manufacturing Organizations (CDMOs) for API and DP manufacturing for Kardigan’s portfolio of assets across its cardiovascular pipeline.  You will ensure the seamless production scheduling, distribution, and logistics of APIs and DPs to support clinical and commercial programs by fostering strong partnerships with external manufacturers to meet corporate objectives.  Responsibilities include contracts negotiation & life cycle management within Tech Ops, CDMO project management, performance and business relationship management.  This role requires collaboration with the Development, Quality, Analytical, Regulatory, and Supply Chain organizations at Kardigan.  This is a 4-day, onsite position, based in South San Francisco, CA.

Essential Duties and Responsibilities:

• Develop and implement comprehensive strategies for external manufacturing, ensuring alignment with the company’s clinical and commercial goals

• Support the selection, qualification, and management of CDMOs for API and DP manufacturing, ensuring robust supply chain continuity
• Collaborate closely with CMC technical leads to manage end-to-end external manufacturing operations, including technology transfer, process validation, production planning, and timely delivery of APIs and DPs
• Ensure efficient distribution and logistics guaranteeing safe, compliant and timely delivery of APIs and DPs
• Establish and maintain strong relationships with CDMOs, conducting regular business reviews to monitor performance, compliance, and continuous improvement initiatives
• Negotiate contracts and manage budgets associated with external manufacturing and logistics services
• Manage the tactical manufacturing strategy, execution of the business with CDMO organizations, and management of vendor performance.
• Work closely with internal stakeholders, including Technical Operations, Supply Chain, Regulatory Affairs, and Quality, to ensure seamless integration of external manufacturing activities with internal processes
• Provide strategic input into CMC development plans and regulatory submissions related to external manufacturing
• Lead development and implementation of External Manufacturing processes and tools for TechOps team
• Implement and monitor key performance indicators (KPIs) to assess and improve CDMO performance

Qualifications:

• 10+ years of experience in Supply Chain, Manufacturing, or other Supply Chain discipline, preferably in the Biotechnology / Pharmaceutical industry
• Proven track record in managing relationships with CDMOs and overseeing complex supply chains in a global environment (At least 3 years of experience in external manufacturing / alliance management / CDMO site management / Supplier management).
• • B.A. or B.S. or equivalent, experience in pharmaceutical sciences, supply chain or related field.  

• Experience with technology transfer, process validation, and commercialization of pharmaceutical products
• Demonstrated ability to lead cross-functional teams and drive complex projects to successful completion
• Extensive knowledge of regulated manufacturing, GMP, GCP and quality systems.  
• Solid understanding of the CDMO landscape, knowledge of CDMO capabilities and limitations worldwide (Small molecule API and drug product manufacturing knowledge is a plus).
• 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 collaborate effectively in a dynamic, cross-functional matrix environment.    
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