Represent Analytical Sciences at CMC teams for multiple programs as a full-time analytical lead. Lead analytical matrix team, establish development plan and timeline to meet CMC team needs. Lead product characterization, CQA assessment, method development/optimization, setting scientifically justifiable comparability strategies, specification, and control strategies. Author, review and/or approve key documents such as: comparability protocols and reports, justification of specifications, and rel... more details
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 crafts 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 groundbreaking 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 efficiency 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 growing collaboration between teams.
Summary of the group:
As a Senior Scientist or an Associate Principal Scientist, Analytical Sciences in Gaithersburg, MD you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer an outstanding and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we cultivate and build top talent.
Main Duties and Responsibilities
- Represent Analytical Sciences at CMC teams for multiple programs as a full-time analytical lead. Lead analytical matrix team, establish development plan and timeline to meet CMC team needs.
- Lead product characterization, CQA assessment, method development/optimization, setting scientifically justifiable comparability strategies, specification, and control strategies.
- Author, review and/or approve key documents such as: comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.).
- Lead cross-functional team to develop business processes and guidelines for integrated early and late stage analytical development activities in support of biologics commercialization.
Essential Requirements
A degree in chemistry, biochemistry or related field with relevant experience.
- For Associate Principal Scientist position
- BS with 15+ yrs experience
- MS with 13+ yrs experience
- PhD with 7+ yrs experience
- For Senor Scientist position
- BS with 10+ yrs experience
- MS with 8+ yrs experience
- PhD with 0+ yrs experience
Desirable Requirements
- Experiences with serving as an analytical lead for CMC teams and interacting with other CMC functions including process, formulation, bioassay and lot release/ stability for cross functional collaborations.
- Significant and established experience in the biopharmaceutical industry with relevant experience in early/ late stage product characterization, risk assessment, method development, optimization, validation, regulatory filing, and response to agency questions.
- Theoretical/ hands on knowledge with methods used for biopharmaceutical characterization including mass spectrometry, liquid chromatography, electrophoresis and other physicochemical technologies.
- Experience with regulatory submissions (IND, BLA, MAA, JNDA). Deep understanding of regulatory requirements for development and commercialization of biopharmaceuticals.
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 groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.
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.”
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?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Date Posted
31-May-2024
Closing Date
Our 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.
