Associate Director, Post Production & Quality Operations

Position Overview: The role oversees multiple reconditioning lines and is responsible to ensure necessary production metrics are consistently met.  What you’ll be doing: * Oversee multiple reconditioning lines within the Inspection & Reconditioning Center (IC), planning production for a full working shift. * Fully manage facilities to meet or exceed targets in production, cost, and quality when the General Manager is not onsite.  * Quickly identify bottlenecks that affect site throughput and efficiency. Conduct root cause analysis, develop action plans, and  execute with the site leadership team and associates. * Conduct weekly site performance reviews with Senior Reconditioning leadership, reporting on performance versus targets, challenges, and countermeasures. * Guide daily site manager huddles to establish the day’s tone and priorities. * Aid in the execution of Continuous Improvement projects at home site and, if applicable, throughout the region/network, while implementing and training process changes. * Foster growth and development in our Reconditioning Lead and Manager populations by supporting Development Plans and providing regular competency-based feedback. * Embody Carvana values through effective leadership, teamwork, and communication on the shop floor. * Uphold Carvana operating standards and processes. * Ensure compliance with all health, safety and loss prevention guidelines. What the job requires: * Must be open to relocation, ideally nationwide but at minimum regionally (Northeast, Southeast, Midwest, West Coast). * Ability to maintain high volume and high-quality content in a fast-paced environment. * Experience leading a team of over 50 associates and a track record of developing employees. * Proven ability to solve urgent operational challenges through root cause analysis. * Excellent communication skills. * 8+ years of management experience either in an automotive or lean manufacturing environment. * Valid unrestricted driver’s license with a clean driving record in the last 3 years. * Must be able to read, write, speak and understand English. * Must be at least 18 years of age. * Requires standing for extended periods of time with frequent stretching, reaching, walking, stooping, pushing, and/or pulling in an environment that may be cold, hot, noisy, and wet and may have fumes or odors due to vehicle maintenance. * Requires use of safety equipment that may include but not limited to face shield or goggles, non-slip shoes, gloves, mask, and other protective garments and equipment. * Ability to work variable schedule(s) as necessary. * Must be able to lift up to 60 pounds independently; majority of lifting from knee to shoulder heights; other lifting required from various levels. * Must be able to walk up to three miles each day.   Other requirements To be able to do your job at Carvana, there are some basic requirements we want to share with you. * Must be able to read, write, speak and understand English. Of course, we’ll make any reasonable accommodations for those with disabilities to perform the essential functions of their jobs.   Legal stuff Hiring is contingent on passing a complete background check. This role is not eligible for visa sponsorship. Carvana is an equal employment opportunity employer. All applicants receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, marital status, national origin, age, mental or physical disability, protected veteran status, or genetic information, or any other basis protected by applicable law. Carvana also prohibits harassment of applicants or employees based on any of these protected categories.   Please note this job description is not designed to contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Description Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. SUMMARY BioMarin is seeking an experienced and motivated Associate Director to join our Combination Products and Medical Devices team. This role is pivotal, encompassing strategic and technical responsibilities. This role provides an opportunity to leverage your device development expertise to develop transformational drug delivery technologies for BioMarin to meet our long-term aspirations. To deliver on this, the candidate must have a proven track record of success working cross-functionally at senior levels and have experience engaging with all functions involved with device development. The ideal candidate will exhibit a strong technical background in drug delivery systems, deep experience in leading cross-functional device team leadership, including experience in combination product development, device/combination product manufacturing operations, and drug product development, with a proven track record of successful device/combination product development and commercialization. This role requires managing senior level stakeholders, a deep understanding of ISO requirements, medical device regulations, and experience in combination products/device development from inception through commercialization and life cycle management. This role demands a high level of expertise in systems engineering fundamentals, mechanical product and process design as well as collaborative operation within a cross functional matrix team environment. RESPONSIBILITIES Lead highly visible cross-functional project teams in developing complex delivery device and combination product technologies with the goal of clinical introduction, commercialization, and post marketing support. As needed, lead technology development of unique drug delivery technologies. Partner with key stakeholders like CMC teams, asset teams, quality, regulatory, external operations and other functions. Lead external device vendor engagement and strategic oversight of externally developed device technologies. As a device team leader, drive the design, development, verification, validation, and transfer of combination products and medical devices. Lead product and process improvement related to on market products. Work closely with contract manufacturers to ensure quality and timely delivery of project deliverables. Prepare and present reports to senior management on project status, risks, and opportunities. Mentor engineers and scientists within the department. Knowledge of global regulatory requirements and industry standards. Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities. Other duties as assigned. EXPERIENCE Required Skills: Minimum 8 years of experience in the development and commercialization of parenteral combination products and medical devices. Demonstrated ability to manage cross-functional teams and collaborate effectively with stakeholders. Firsthand experience with parenteral drug delivery with device technologies like pre-filled syringe, autoinjectors, large volume delivery technologies is highly desirable. Deep expertise in design controls. Experience working with contract manufacturers. Exposure to human factors engineering. Working with regulatory agencies and ensuring compliance with industry standards. Effective communication skills and demonstrated ability to influence up, down, and across multiple levels and functional areas (corporate wide). Desired Skills: Worked at large-mid sized pharma and/or biotechnology companies focused on developing parenteral combination products. Led cross-functional device teams and commercialized prefilled syringes, autoinjectors, and/or pen devices Worked with industry standard primary container technologies like prefilled syringes, cartridges, and vials Experience with lyophilized product related drug delivery EDUCATION Bachelor’s degree in engineering, Life Sciences, or a related field. Advanced degree preferred. CONTACTS Device engineers, device quality, device regulatory, external manufacturing, drug product formulation scientists, supply chain engineers, asset team members like clinical and commercial. ONSITE, REMOTE, OR FLEXIBLE Hybrid. 3 days a week in Novato TRAVEL REQUIRED Up to 10% domestic and international travel Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training. Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.