Senior Scientist Dosage Form Design and Development

  • AstraZeneca
  • Gaithersburg, Maryland
  • Full Time

Senior Scientist Dosage Form Design and Development

Are you driven by a passion for science and eager to make a tangible impact on patients' lives? At AstraZeneca, we transform scientific ideas into life-changing medicines, always putting patients first. Join us in the Late-Stage Formulation Sciences group, where we develop innovative products through exceptional science and forward-thinking execution. Our mission is to deliver high-quality biologics to the market, ensuring robust formulations and drug products that meet regulatory standards. If you're ready to lead, collaborate, and explore the possibilities of science, this is your opportunity!

Accountabilities:

- 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 the late-stage portfolio and manage the life cycle 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 biopharmaceutical development.

Essential Skills/Experience:

- BS in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with 10+ years of experience, MS with 8+ years of experience, or PhD with 0+ years of experience.
- 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 commitment to results.

Desirable Skills/Experience:

- Understanding of clinical dosage preparation and administration practices is highly desired.
- Knowledge of risk assessment 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.
- Experience with inspections and audits by providing guidance to audit team and/or managing responses to auditors.

At AstraZeneca, we are at the forefront of transforming cancer treatment through our pioneering Oncology pipeline. Our collaborative environment encourages bold moves that challenge conventional thinking, driving us to discover novel solutions for patients worldwide. With access to unparalleled data and a global network of experts, we foster a culture of courage and innovation. Join us in shaping the future of Oncology by pushing the boundaries of science and making a meaningful difference in patients' lives.

Ready to take the next step in your career? Apply now to join our team at AstraZeneca!

The annual base pay for this position ranges from $ 112,164.00 - 168,246.00. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

07-Jul-2025

Closing Date

30-Aug-2025Our 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.
Job ID: 484345848
Originally Posted on: 7/7/2025

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