Principal Scientist/Director, Mrna Cmc Drug Product Development

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
About AstraZeneca in Gaithersburg, MD:
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. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
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.
Summary of the group:
The mRNA Drug Product Development Team is a part of the Dosage Form Design and Development group of Biopharmaceutical Development. The team's purpose is to advance the development of mRNA products and processes, including manufacturing of lipid nanoparticles (LNPs) to deliver life-changing vaccines and medicines to our patients . This purpose is realized through an application of a wide range of scientific disciplines converging to bridge between formulation and device capabilities and providing leadership from early research through CMC activities for mRNA delivery technologies. Areas of focus include:

• Strong collaboration with Pharmaceutical Sciences Advanced Drug Delivery team to enable identification and selection of appropriate lipids and LNP composition for downstream development activities
• Lead CMC activities across Dosage Form Design and Development to enable optimization of RNA-LNPs to a platform state
• Identification of new technologies to employ for product and process understanding
• Identification and initiation of key collaborations to advance mRNA-LNP platform development and product understanding
• Strategic insight for Technology Development in Dosage Form Design and Development

Main Duties & Responsibilities:

• Serve as a key collaborator and partner for advancement of lipid selection and LNP composition with internal Advanced Drug Delivery team
• Serve as a CMC DP activity leader for AstraZeneca nucleic acid programs providing oversight and execution of all elements of CMC delivery post Lead Optimization through clinical trials.
• Lead the development of customized drug delivery formulations for non-viral delivery of various nucleic acids to support several therapeutic areas
• Provide technical expertise, design and execute experiments, analyze and present experimental data and sound recommendations
• Act as SME in project teams and across the organization
• Identification and evaluation of external technologies to support advancement of AstraZeneca's internal mRNA-LNP manufacturing platform

Education & Experience Requirements:

• Ph.D. degree in a relevant discipline (such as Biopharmaceutics, Pharmaceutics, Chemical Engineering, or Drug Delivery) with 8+ years of experience in relevant work

Required Skills:

• Good understanding/knowledge of the overall drug development process and knowledge of CMC attributes that define formulation robustness.
• Relevant industrial experience within drug delivery formulations for nucleic acid delivery (nanoparticle delivery technologies)
• Practical experience with nanoparticle formulation using various fabrication processes, analytical characterization and accurate data reporting
• Relevant experience with end-to-end nanoparticle and microparticle production processes for encapsulation of nucleic acids and biologics
• Flexibility and the ability to adjust to changing priorities and operate in a fast-paced industry environment.
• Excellent oral and written communication skills; experience working in multidisciplinary teams

Desired Skills:

• Leadership and stakeholder management skills
• Ability to navigate ambiguity and synthesize actionable next steps to move programs and strategies forward
• Track record of scientific competence in terms of publications, presentations and networking activities

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 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 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 recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.
Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
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Date Posted
07-Nov-2023
Closing Date
AstraZeneca 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, sex, sexual 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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.