Scientist I/II - Formulation Sciences - BPD
Scientific position responsible for commercial formulation development of biologic products. Design and execute formulation risk assessments and characterization studies, and develop formulation control strategies for Drug Substance and Drug Product. Ensure robustness of intended commercial formulations, suitability for intended use of container closure/packaging systems, and in-use compatibility with clinical administration components. Exercise technical discretion and scientific rigor in experimental protocol design, data analysis, and results interpretation. Author marketing applications and support regulatory responses to product approval. Support lifecycle management of commercial products. Develop new strategies and approaches to advance late-stage formulation development and deliver scientific and operational objectives.
Knowledge of protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, combination drug products, and/or biophysical analytical methods is required. Hands-on experience with high-performance size exclusion chromatography (HPSEC), particle characterization and sizing (e.g. light obscuration), and aggregate characterization methods are strongly preferred. Experience with formulation and biopharmaceutical development, characterization, control strategy, quality risk management, and/or CMC regulatory guidance and BLA filings is preferred.
Scientist I: B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with a minimum of 10 years of experience, M.S. with a minimum of 8 years of experience, or Ph.D. with 0-3 years of experience.
Scientist II: B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with a minimum of 13 years of experience, M.S. with a minimum of 10 years of experience, or Ph.D. with 3 years of experience.
Skills and Abilities:
Leading, planning, and executing complex projects on tight timelines are important. High degree of self-motivation and drive for results are critical. Develops creative solutions to complex problems, but likewise proficient at anticipating and heading off potential issues. Demonstrates strong scientific thinking and project organizational skills to navigate projects forward. Effectively and efficiently explains and presents complex scientific concepts to diverse audiences. Displays ability to resolve conflicts through effective interpersonal communications and cross-functional collaborations. Excels at making good decisions, priority setting, and mentoring team members.
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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. 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.