What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.Why UsIllumina Laboratory Services (ILS) is an exciting and rewarding organization that applies Illumina’s core sequencing and array technology to sustain existing Illumina’s service offering while driving implementation of new assays and technologies into clinical laboratory service offering. Illumina lab services works cross functional to meet customer demands while also exploring new offerings within the clinical space.Why YouYou are an expert in lab development with demonstrated experience in independently developing new methods, complex troubleshooting and scaling new assays. You have experience in directing and managing team including providing technical oversight around development. You see yourself as someone who can work cross functionally to assess concept and feasibility of new service offerings and execute on defined plans. You have experience working in a clinically regulated environment and can adhere to CAP/CLIA practices. You thrive in areas of ambiguity where you will need to be flexible and agile. You like to solve problems and propose solutions and have demonstrated that in development space. You thrive within a fast-paced environment. You are passionate about improving human health by making a direct impact with your work on products that are being used in clinical services.The roleAs the Director of Development and Engineering, you will use your extensive understanding of development practices to manage the Development and Engineering team, providing mentorship, direction, and coaching to achieve department goals. You will be responsible to maintain and refine organizational agility for supporting automated and manual scale assay offerings through various lifecycle stages. You will lean on your expertise of implementing assays and technologies in a high complexity molecular testing environment with scaled operations. You will be a technical expert within a multi-disciplinary team working to ensure ILS products meet their stated claims, global regulatory requirements, and customer expectations.ResponsibilitiesDirect, mentor, and coach a multi-site team of managers, engineers, and scientists responsible for end-to-end lifecycle management of service laboratory assay portfolios currently including direct to consumer genotyping, non-invasive prenatal testing, oncology panel sequencing, and whole genome sequencing applications in oncology and rare and undiagnosed genetic disease.Direct validation and verification strategies for assay transfer to Clinical Laboratory, appropriately balancing regulatory requirements against budget and timeline needs.Develop and drive adherence to annual development budgets for development and sustainment activities to support the ILS test menu.Establish and maintain close collaborations with Illumina product development groups to maintain awareness of product development pipeline and potential for opportunities within ILS.Work with key stakeholders to assess concept and feasibility of new service applications and opportunities within ILS.Drive culture of change and continuous improvement across organization, while adhering to regulatory requirements and best practices in clinical laboratories.Work with ILS software and bioinformatics leadership to provide user requirements for information management systems, as necessary.Maintain and refine organizational agility for supporting automated and manual scale assay offerings through various lifecycle stages.Drive cross-functional alignment to meet and maintain CLIA/CAP/NYS regulatory requirements during development, validation, and study design execution.RequirementsBachelor’s Degree in Biological Sciences, Engineering, or related field with minimum of 18 years of relevant industry experience.10+ years management experience in a laboratory environment, ideally in a clinical high complexity molecular testing environment with scaled operationsSpecific experience in whole genome and transcriptome applications within Oncology strongly preferredProven track record of designing and implementing Next Gen Sequencing assays and technologies into a clinical laboratory service.Demonstrated experience in characterization and testing of complex systems, including design of experiments and root cause analysisDemonstrated success in building and growing innovative development and engineering teams.Demonstrated verbal and written communication skills with senior leadershipTrack record of strong interpersonal skills to collaborate and lead change in cross-functional teams10% travel requiredThe estimated base salary range for the Director, Assay Development and Validation role based in the United States of America is: $163,900 - $245,900. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. 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