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Global Technical Operations, Director, RadioConjugates
Location:
Gaithersburg, MD
Description:
Introduction to role: Join us in a cross-functional leadership role within the Global Technical Operations (GTO) team, focusing on the strategic planning and coordination of technical leadership for our radioconjugate platforms. This role is a unique opportunity to make an impact on society through our sustainability goals and be a key contributor to Zero Carbon by 2025 and carbon negative across the entire value chain by 2030. Accountabilities: As the GTO New Modalities and Technology Director, you will act as the early MS&T and platform owner for RadioConjugates, leading Operations engagement with various development technical and leadership teams. You will establish and lead Operations standard work, drive harmonized processes for commercializing platforms for Radio conjugates, and act as the Subject Matter Expert for site engineering efforts. You will also consult on aseptic fill, formulation and lyophilization development, process design and validation, and coordinate partnership of GTO team with Regulatory, Quality Assurance, and CMC teams. Essential Skills/Experience: Bachelor's degree and eight plus years of experience is required.Extensive knowledge of critically relevant areas such as analytical characterization, formulation, and the general CMC scope for RadioConjugates.Experience in a Commercial/late stage manufacturing settingProven history of regulatory document authoring or regulatory technical strategy developmentBachelor of Science with 10+ Years of experience in biologics manufacturing; 7+ years with advanced degreeThe ability to co-create and collaborate in complex and agile environmentsAbility to advance projects against accelerated timelines, clearly define go/no go decisions points, with a focus on execution.Experience with Project Management (budgeting, timelines, resourcing, planning).Excellent communication skills, highly effective in interacting with key internal and external stakeholders.Strong organizational and coaching skills. Desirable Skills/Experience: Master's degree preferred.Late phase/commercial experience in resin evaluation, selection and platformization, including resin selection experimental designFacility engineering, commissioning and qualification experienceAseptic fill finish characterization and validationLyophilization characterization and validation experienceDemonstrated leadership in expedited yet thorough evaluation of emerging technologyAbility in influence and balance the interests of multiple stakeholders while ensuring resultsProficiency with PowerBI, PowerAutomate and Microsoft Office suite of toolsUnderstanding and competency in DoE study designWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Why AstraZeneca? At AstraZeneca, we are driven by our commitment to deliver accelerated growth and to make people's lives better. We are part of an inclusive and giving community where we support each other on our journeys. We are disciplined thinkers and doers who thrive in our often intense and ambiguous environment. We are leading the way in delivering Lean processes that drive greater efficiency and speed. Sustainable practices are at the heart of what we do, ensuring we manage our environmental impact across all our activities and products.Are you ready to make a difference? Join us in our mission to deliver more medicines to patients, quicker and more affordably. Apply today! Date Posted 16-Apr-2024 Closing Date 29-Apr-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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More About this Listing: Global Technical Operations, Director, RadioConjugates
Global Technical Operations, Director, RadioConjugates is a Executive Director Job at Astrazeneca located in Gaithersburg MD. Find other listings like Global Technical Operations, Director, RadioConjugates by searching Oodle for Executive Director Jobs.
Global Technical Operations, Director, RadioConjugates is a Executive Director Job at Astrazeneca located in Gaithersburg MD. Find other listings like Global Technical Operations, Director, RadioConjugates by searching Oodle for Executive Director Jobs.