Scientist/Senior Scientist - Late Stage Formulation Sciences | Gaithersburg, MD

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 Astra Zeneca 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: As a part of Biomedical Development, the Late-Stage Formulation Sciences group, within the department of Dosage Form Design

and Development, is on a mission to develop extraordinary products through excellent science, forward-thinking execution, and compassion for patients and those who touch our products.

We develop and characterize intended commercial formulations and finished dosage forms to deliver high quality biologics to the market for patients. We develop robust formulations, Drug Products, and product control strategies to ensure approval of marketing applications for product commercialization and launch. The Late-Stage Formulation Sciences (LSFS) Group is responsible for development of intended commercial formulations to advance Astra Zeneca's late stage biologics portfolio, and the life cycle management of commercialized products.

The group plays an integral part in the design and development of patient centric drug products. Main Duties & Responsibilities (Scientist): Laboratory-based position responsible for independently designing and implementing experiments for late-stage formulation development of biologics, including product characterization, stability, and in-use compatibility studies Exercise technical discretion and scientific difficulty in experimental protocol design, data analysis, and results interpretation Develop new methods, technologies, and approaches as needed to advance projects to BLA submission and approval Effectively present findings in departmental and inter-departmental meetings and prepare technical reports Main Duties & Responsibilities (Sr.

Scientist): Provide scientific and matrix leadership for late-stage formulation development of biologics Responsible for project decisions and deliverables, scientific and organizational objectives. Lead development of intended commercial formulations and drug products to advance late-stage portfolio, and life cycle management of commercialized products. Author and review marketing applications and support regulatory responses to approval.

Coordinate with collaborators to ensure seamless end-to-end product development, and drive scientific initiatives and innovation through personal leadership. Design and implement scientific and business strategies integrated across biomedical development. Education & Experience Requirements: Scientist: Bachelor's degree with demonstrated ability OR Master's degree with 2+ years of experience Senior Scientist - BS in chemistry, biochemistry, medical sciences, engineering, applied sciences, or related field with 10+ years of experience, MS with 8+ years, or Ph D with 0+ years.

Required Skills: Hands-on experience with biological characterization methods including analytical and biophysical techniques - high-performance size exclusion chromatography (HPSEC), particle characterization and sizing (e. g. light obscuration, micro-flow imaging), and aggregate characterization methods Experience with protein formulation and drug product development. In depth knowledge of protein biochemistry and degradation pathways Effective interpersonal skills to work in teams and to present complex scientific concepts Ability to work independently and to influence team decision-making High degree of self-motivation and commit to results Desired Skills: Understanding of clinical dosage preparation and administration practices is highly desired.

Knowledge of risk backssment methodologies and CMC regulatory guidance is a plus Skills leading, planning, and implementing complex projects on tight timelines are important Experience with study design (Design of Experiment) and statistical data analysis using JMP or Minitab software is highly desired. Why Astra Zeneca? At Astra Zeneca 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-medical company can be. This means we're opening new ways to work, pioneering innovative 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 careers. /bpd Our Social Media, Follow Astra Zeneca on Linked In /company/1603/ Follow Astra Zeneca on Facebook /astrazenecacareers/ Follow Astra Zeneca on Instagram /astrazeneca_careers/? hl=en Date Posted 01-Nov-2023 Closing Date Astra 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.