Senior Scientist

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Bring out the best in each other, and yourself, by working together as one.  In our dynamic environment, be supported by the brightest minds, Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace. 

Description of Responsibilities:

This role is inGlobalProduct Development and supports AZ’s pressurized metered dose inhalers (MDIs)and oral solid dosage forms throughmid tolate stageproduct development activities. The ideal candidate will havedrugdevelopment experience with combination products, including inhalation products. Moreover, knowledge and experience in howsuspensionMDI formulations interact with the valve, can, and actuator isrequired. In addition, the candidate should have strong problem solving and communication skills with the drive and leadership qualities needed to deliver on project goals.

Essential:

• Bachelor's Degree
• Minimum 3+ years of experience
• Excellent written and verbal communication skills
• Collaboratewithbothinternal and external partners (e.g.analytical,cRO/cMOs,academic institutions,manufacturing, formulation, device,quality assurance,statistics,andregulatory affairs)to effectively deliver onproject and team objectives
• Effectively plan,completeandcommunicate technical developmentactivitieswithin AZ project teams
• Working knowledge of key analytical characterization techniques (e.g.Karl Fischer moisture analysis, HPLC, pH, solid state particle analysis)
• Lead/Authorcomplex technical protocols for the development ofdrugproducts using both internal and external resources
• Lead/participateintechnical development teams with focus on product development, characterization, root causeanalysisandrisk mitigation
• Lead/participateindrug productprojecttechnical investigationsand provide analysis/recommendations to team 
• Prioritize and interpret large data sets and communicate data impact or value to senior R&D leadership. 
• Contribute to/and or lead continuous improvement projects and other GPD initiatives
• Maintainlab notebooksfollowing SOP requirements and keep clear and complete records. Ensure GMP/GLScompliance 
• Maintainlabequipmentand labenvironmentsfollowing SOP requirements and keep clear and complete records. Ensure GMP/GLS compliance
• Complete procurement activities for lab/project (Requestioning, PO generation, invoicing)
• Ability to work inalaboratory environment for up to 50% of time, conductingcharacterization testing, formulation development, spray drying development activities
• Abilityto work in office environment and familiarity with PCs (MS officeproficiencyrequired)

Desirable:

• Experience authoring US and international regulatory documents is desired.
• Author sections of regulatory documents (e.g., DMFs, INDs, NDAs, etc.)
• Participate/lead the interactions with Health Authorities for regulatorymeetings.
• Familiarity with Leanand orSix Sigma
• Familiaritywith JMP statistical software

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.