Director Contract Manufacturing Operations Job at Veracyte in San Diego

At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte - whether it be in one of our labs, corporate offices, the field - enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a results-driven environment that values innovation, collaboration, and compassion.The Position:The Director Contract Manufacturing Operations will be responsible for overseeing the full lifecycle of outsourced manufacturing for IVD/FDA regulated clinical products. This includes selecting Contract Manufacturing Organizations, managing the transfer of manufacturing processes, and ensuring ongoing operational performance through established KPIs. The role requires close collaboration with internal stakeholders such as Product Development, Market Access, Quality, Regulatory, and Supply Chain to ensure compliance, quality, and timely delivery of products. Key Responsibilities: Lead the evaluation and selection process for CMOs, including due diligence, capability assessments, negotiations, and contracting. Develop and manage CMO relationships to ensure alignment with manufacturing strategies and IVD/FDA requirements. Plan and manage the tech transfer of manufacturing processes to CMOs, ensuring seamless execution and compliance with quality and regulatory standards. Collaborate with development teams to develop transfer protocols, process validations, and QC/troubleshooting strategies. Establish clear communication channels and governance for monitoring transfer progress. Define, implement, and monitor KPIs for CMO performance, including production output, quality metrics, cost management, and compliance standards. Develop corrective and preventive action plans for any performance deviations, ensuring adherence to timelines and quality standards. Lead regular business reviews with CMOs, assessing performance and driving continuous improvement initiatives. Work closely with internal teams including Development, Quality, Regulatory, Technical, and Supply Chain to align CMO activities with broader operational and strategic objectives. Ensure that all CMO operations meet regulatory compliance, particularly IVDR requirements including participation in quality/regulatory audits. Facilitate cross-functional meetings to review CMO performance, discuss potential risks, and develop mitigation plans. Drive operational efficiency in CMO management, focusing on cost, quality, and delivery improvements. Proactively identify and address risks associated with CMO operations, ensuring robust contingency plans are in place. Implement best practices in CMO management, including supplier development, risk assessment, and lifecycle management. Provide strategic guidance to senior leadership on CMO-related matters, contributing to long-term planning and operational strategies. Qualifications: Bachelor's degree in a scientific, engineering, or related field; advanced degree preferred. 10+ years of experience in manufacturing operations, with at least 5 years in a CMO management role, ideally in the medical device or diagnostic sectors. Strong understanding of IVD/FDA requirements and experience managing IVDR and FDA-compliant manufacturing processes. Proven experience in tech transfer, manufacturing process optimization, and KPI management. Excellent leadership skills with the ability to influence and collaborate across functions. Strong analytical, problem-solving, and decision-making skills. Ability to travel as needed to CMO sites.#LI-HybridThe final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. Veracyte is a multi-state employer, and this salary range may not reflect positions that work in other states.Pay range$180,000-$220,000 USDWhat We Can Offer YouVeracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are proud to have been named a "Bay Area Top Workplace" for 11 years in a row by the Bay Area News Group and "Best Places to Work in San Diego" in 2023 by the San Diego Business Journal.About VeracyteVeracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company's growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The company's tests in lung cancer, prostate cancer, breast cancer, thyroid cancer, bladder cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping and renal cancer tests are in development. With Veracyte's exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on X (Formerly Twitter).Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E-Verify in the United States. View our CCPA Disclosure Notice.If you receive any suspicious alerts or communications through LinkedIn or other online job sites for any position at Veracyte, please exercise caution and promptly report any concerns to careers@veracyte.com