Commercial Product Senior Scientist, Global Technical Operations
At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK.
In Biologics Global Technical Operations (GTO), we work closely with AstraZeneca's manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline. The Commercial Product Senior Scientist focuses on global end-to-end technical support of commercial biologics products. The selected individual will work closely with commercial product CMC teams and Product Champions to provide in-depth technical oversight and tactical technical leadership for the assigned commercial products throughout the commercial lifecycle.
What you'll do:
Essential for the role:
- Drive implementation of and improvements to standard work and business processes across commercial CMC teams for the Biologics portfolio. Closely collaborate with Product Champions and CMC project managers to ensure all required standard work is executed in commercial CMC teams.
- Maintain the oversight of the process for the products assigned from drug substance raw materials through drug product primary packaging by ensuring all critical variables are tracked as appropriate for the assigned products.
- Oversee and drive uplift of digital capabilities within Global Technical Operations with a focus on improving access to and analysis of process data from external manufacturing partners as well as product knowledge management initiatives.
- Management of Lifecycle and Post Approval Changes through development of strategy and implementation plans for global post-approval changes. Work with CMC Project managers to develop detailed implantation timelines and work with CMC team and internal and external stakeholders to ensure implementation to plan while assessing the product impact of manufacturing changes.
- Degree in an engineering or scientific subject area with experience in biopharmaceutical manufacturing/development/process engineering:
- B.S with 7+ years of experience
- M.S. with 5+ years of experience
- PhD with 1+ years of experience
- Proven technical knowledge of commercial biologics manufacturing with direct experience with biologics manufacturing or development.
- Broad based understanding of Operations including Manufacturing Operations, Supply Chain, Quality Assurance, and Quality Control.
- Strong communication skills with the ability to successfully influence across levels and functions.
- Ability to work in a complex, dynamic, global environment; thinking strategically and balancing both long and short-term priorities.
- Experience with data analytics and digital transformation strongly desired.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.Find out more on Social Media:
About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
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