Senior Scientist

AstraZeneca•Durham, NC

About The Position

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 in Global Product Development and supports AZ’s pressurized metered dose inhalers (MDIs) and oral solid dosage forms through mid to late stage product development activities. The ideal candidate will have drug development experience with combination products, including inhalation product s . Moreover, knowledge and experience in how suspension MDI formulations interact with the valve, can, and actuator is . In addition, the candidate should have strong problem solving and communication skills with the drive and leadership qualities needed to deliver on project goals.

Requirements

Bachelor's Degree
Minimum 3+ years of experience
Excellent written and verbal communication skills

Nice To Haves

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 regulatory meetings.
Familiarity with Lean and or Six Sigma
Familiarity with JMP statistical software

Responsibilities

Collaborate with both internal and external partners ( e.g. analytical , cRO / cMOs , academic institutions, manufacturing, formulation , device, quality assurance, statistics, and regulatory affairs ) to effectively deliver on project and team objectives
Effectively plan, complete and communicate technical development activities within AZ project teams
Working knowledge of key analytical characterization techniques (e.g. Karl Fischer moisture analysis, HPLC, pH, solid state particle analysis)
Lead/Author complex technical protocols for the development of drug products using both internal and external resources
Lead/ participate in technical development teams with focus on product development, characterization, root cause analysis and risk mitigation
Lead/participate in drug product project technical investigations and 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
Maintain lab notebooks following SOP requirements and keep clear and complete records.
Ensure GMP/GL S compliance
Maintain lab equipment and lab environment s following SOP requirements and keep clear and complete records.
Ensure GMP/GL S compliance
Complete procurement activities for lab/project (Requestioning, PO generation, invoicing)
Ability to work in a laboratory environment for up to 50% of time , conducting characterization testing, formulation development, spray drying development activities
Ability to work in office environment and familiarity with PCs (MS office proficiency )