Director, Drug Product Development

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}"> </span></p> <div data-olk-copy-source="MessageBody">Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.<br><br></div> <div>It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.</div> <div> </div> <div>Led by Tassos Giannakakos, Jay Edelberg, <span data-olk-copy-source="MessageBody">M.D., Ph.D.,</span> 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.</div> <div> </div> <div>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.</div> <div> </div> <div>At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. <strong>Driven by patients and their families</strong>, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in <strong>being authentic</strong>—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 <strong>eagerness to learn</strong>, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to <strong>winning as a team</strong> with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to <strong>enable the impossible</strong> because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.</div> <div> </div> <div>These values are the foundation of our work, empowering us to make a real difference, every day.</div> <div> </div> <div> </div></div><h2>About this role:</h2> <p>Kardigan is seeking a Director, CMC Drug Product Development, to support development of late phase projects. This role will report directly into the Head of Drug Product Development.</p> <p>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 South San Francisco or Princeton NJ.</p> <p><strong>Responsibilities:</strong></p> <ul> <li>Lead drug product development for both early phase and late phase assets.</li> <li>A member of CMC project teams accountable for all drug product development and manufacturing activities to support both early and late phase projects.</li> <li>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.</li> <li>Ensure formulation and drug products meet the target product profile necessary to enable the successful commercialization of the product.</li> <li>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.</li> <li>Develop, review, and approve manufacturing batch records, manage internal batch release activities.</li> <li>Establish appropriate drug product specifications and stability studies in partnership with Analytical, Quality, CDMOs, Regulatory, and other subject matter experts to support intended use.</li> <li>Write and review protocols, reports, and drug product sections for regulatory documents.</li> <li>Contribute to product investigations and conduct root cause analysis.</li> <li>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.</li> <li>Collaborate with legal and procurement to review contract terms and execution of agreements.</li> <li>Keep up with the latest regulatory and cGMP guidance and awareness of state-of-the-art manufacturing practices.</li> <li>Monitor status of CDMO capacity, manage risks and make recommendations to Kardigan’s leadership team.</li> <li>Manage the negotiation of contracts broadly applicable to drug product manufacturing. Ownership of the contract deliverables and obligations.</li> </ul> <p> </p> <p><strong>Qualifications and Experience:</strong></p> <ul> <li>S. or PhD in pharmaceutical sciences, chemical engineering, or a related discipline. Advanced degree preferred.</li> <li>Minimum 10 years' experience within pharmaceutical CMC development and Technical Operations. Experience with both sterile and oral products, including device development is preferred</li> <li>Sound knowledge of formulation development, process engineering and plant operations</li> <li>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.</li> <li>Significant experience in working with global health authorities, IND, IMPD, NDA, MAA etc.</li> <li>Experience with process validation and continuous process improvement.</li> <li>Ideally experience with commercializing small molecule drug products</li> <li>Extensive knowledge of regulated manufacturing, GMP, GCP and quality systems.</li> <li>Creative/innovative/problem solver that actively drives progress.</li> <li>Ability to manage multiple projects in a fast-paced environment.</li> <li>Strong interpersonal communication skills, proven ability to build and maintain collaborative, effective internal and external relationships.</li> <li>Excellent written, oral communication, and presentation skills along with the ability to communicate effectively with senior management.</li> <li>Ability to effectively collaborate in a dynamic, cross-functional matrix environment.</li> </ul> <p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Exact Compensation may vary based on skills, experience and location.</p></div><div class="title">Pay range</div><div class="pay-range"><span>$204,000</span><span class="divider">—</span><span>$266,000 USD</span></div></div></div>