Director, External Manufacturing

Director, External Manufacturing

South San Francisco, California, United States

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 Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients. 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.

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.

Exact Compensation may vary based on skills, experience and location.

Pay range

$205,000 - $267,000 USD