Location: Durham, NC
Company: Astrazeneca
and delivering active ingredients, formulations, and devices required to support new medicines - from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
Make a positive impact, in a team where it means more. In Operations, we have a big ambition. to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking. What you will do: We will rely on you to bring a strong packaging perspective to the department, delivering our packaging strategy in a diverse, multi-skilled
area, and supporting our packaging activities on development projects from Phase 1 to the transfer to Commercial Manufacture. You will work with Development and Operations packaging colleagues across the company.
Lead the development, testing, and validation of all packaging presentations for medical device and combination products to achieve project targets in a timely fashion. Accountable for developing innovative, creative, and cost-competitive packaging solutions that meet the needs and requirements of our patients, our sustainability objectives, and our quality standards. Generate and review regulatory submission documents, plans, protocols, and reports ensuring that the project
objectives are met (Design History File documentation)Contribute and support relevant information to the Design transfer team to enable successful packaging transfer to AZ manufacturing operations and/or contract laboratories Ensure that work is performed in accordance with appropriate safety (SHE), quality and compliance standards.
Influence understanding and interpretation of packaging regulations Represent specialist packaging area (SME) on Device Project Teams, ensuring the provision of appropriate data (technical, resource & budgetary)Understand and Influence developments within the industry Contribute to the training and development of packaging colleagues by acting as coach/mentor as appropriate Minimum Qualifications: BSc/Ph D level education in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in medical Sciences with related experience in the device and biomedical industry.
Minimum 10 years experience Knowledge and application of c GMP requirements, Device and Combination Product requirements, in major medical markets (USFDA, EMA.)Strong technical and scientific skills with proven experience in the development of packaging solutions for parenteral and/or Inhalation products.
Strong experience with medical device or combination product commercialization, operations support, and materials/components. Lean Six Sigma Green Belt or higher certification with strong problem-solving skills Demonstrated ability to simultaneously handle multiple projects of variable complexity. Strong operational relationships with customerinteractionperience of leading cross-disciplinary delivery teams When 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 Astra Zeneca: Be part of shaping the future of Operations here at Astra Zeneca. Be part of shaping the next phase of Operations' journey towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability and efficiency to deliver our new modalities and complex pipeline to market at speed.
Backed by a supportive team, be part of accelerating our operational excellence with innovations in cutting-edge science, Lean ways of working, and fast-changing digital technologies. Call to Action: Ready to make a difference? Apply today! Linked In /company/1603/ Facebook /astrazenecacareers/ Minimum Date Posted 04-Dec-2023 Closing Date 28-Dec-2023Astra Zeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics (e. g. race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability or protected veteran status). We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
Astra Zeneca 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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