Associate Principal Scientist/Engineer (Osd Manufacturing)

Do you want to make a difference for patients by making our commercial products more robust, sustainable, and cost-effective? Apply your experience in Oral Solid Dosage (OSD) manufacturing to support TTs, Scale-up, HAQs, and problem-solving. Work in TOSI, where development and manufacturing meet and make it happen!
We have an exciting opportunity for an Associate Principal Scientist/Engineer - Pharmaceutical Science to strengthen our team! In this role you will work within Technical Operations Science and Innovation (TOSI), a key function of our Pharmaceutical Technology and Development (PT&D) organization.
TOSI is a multi-skilled Global organization based in 13 locations in 7 countries that provides expert technical support for AstraZeneca commercial small molecule drug products, product robustness, manufacturing technology strategy, and Packaging Development and Technology.
We work closely with many technical, supply, and quality functions across Operations providing the ability to drive science and build capability within our organization and our ways of working.
In this role, you will be the responsible expert for a commercial product or group of products related to the Pharmaceutics and/or Engineering subject matter area. Using your expertise and collaborating cross-functionally, you will support AZ manufacturing sites and CMOs to ensure the performance, robustness, and compliance of OSD products and related manufacturing processes. You will play an important role in driving the strategy for commercial OSDs, including digital and sustainability improvement for our commercial OSD products. In doing this, you will get the opportunity to reach across and outside AstraZeneca, drive our future processes, and learn more about OSD manufacturing.
What you will do:

• Identify and drive cross-product or brand challenges, best practices, or improvement opportunities for commercial drug products related to pharmaceutical manufacturing technologies, including increase of yield, reduction of lead time, reduction of carbon footprint, and reduction of CoG.
• Provide technical expertise on process and/or equipment requirements during the transfer of manufacturing processes and/or process scale changes for established products (OSDs) within AZ sites and to external manufacturing partners.
• Lead, assess, and support investigations on deviations and complaints, ensuring suitable corrective and preventative actions are identified.
• Lead and assess the impact of complex technical improvements or change activities e.g. related to processes and/or equipment assuring product performance
• Support lifecycle activities (e.g. change control, continuous process verification, support to GMP inspections) for products under your accountability, to ensure performance and compliance across sites.
• Contribute to regulatory file authoring and review, to support regulatory variations, license renewals, and response to questions from regulatory Authorities.

Minimum Qualifications:

• Master's degree or Ph.D. level or considerable experience post-degree in an appropriate field such as Chemistry, Chemical Engineering, Pharmacy, Pharmaceutical Sciences, or a similar field.
• Minimum 5 years of experience relevant to pharmaceutical oral solid dose manufacturing or pharmaceutical manufacturing.
• Excellent communication and leadership with a demonstration of ability to work across different functions and in an intercultural environment. You will have a lead technical role in global product teams across many functions.
• Demonstrated leadership for product leadership / leading improvement projects related to manufacturing of commercial OSD products
• Good knowledge of OSD manufacturing processes establishment, validation, optimization, and transfer and unit operations for OSD manufacturing (e.g. blending, milling, roller compaction, wet granulation, tablet compression, capsule filling, coating, vision sorting, packing, etc...)
• Excellent experience in issue investigation and change assessment. Good knowledge of standard tools for root cause analysis.
• A thorough understanding of principles, applications, and management of cGMP.

Preferred Qualifications:

• Good understanding of OSD products' life-cycle from late-stage development to launch and through the commercial life cycle.
• Experience in or exposure to multiple fields in CMC and related functions (eg Product Development, Product Manufacturing and testing, Quality Assurance, Regulatory, Stability Biopharmaceutics, Packaging, etc...)
• Previous experience and training in Lean and Six Sigma.
• Experience in data analysis and product performance and trending.
• Understanding, development, and application of process unit operation modeling and simulation tools

Why AstraZeneca
At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference in medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and is always committed to lifelong learning, growth, and development. We're on an exciting journey to pioneer the future of healthcare.
The challenge to stay ahead in rapidly changing markets is what keeps us driving forward, as we continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve.
So, what's next
Are you ready to bring new ideas and fresh thinking to the table? Wonderful!
Date Posted
25-Jan-2024
Closing Date
04-Feb-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.