If you have experience with leading technical development teams, inhalation drug-device combination product development, and looking to build your career in a leading pharmaceutical company, then join us!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking 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.

This role is in Product Development and supports AstraZeneca’s Inhalation mid to late-stage product development activities. The ideal candidate will have development experience with drug-device combination products, including inhalation products, and a working knowledge of medical device design controls. Moreover, knowledge and experience in how suspension MDI formulations interact with the valve, can, and an actuator is required. In addition, the candidate should have strong problem solving and communication skills with the drive and leadership qualities needed to deliver on project goals. Experience authoring US and international regulatory documents is desired.

In 2013, AstraZeneca acquired Pearl to expand and strengthen its respiratory products portfolio, We have made strides in bringing therapies to asthma patients. Our mission and vision are to develop differentiated therapeutics for widely prevalent respiratory disease conditions, including chronic obstructive pulmonary disease (COPD), by utilizing a proprietary drug delivery platform and existing therapeutic agents administered in metered-dose inhalers (MDIs). Join us as Associate Scientist/Scientist at our Durham, NC site, which is situated in Research Triangle Park; the leading center of innovation in the Southeast! We are dedicated to creating a culture of inclusion and teamwork.

What you will do:

• Lead technical development teams with a focus on product development, characterization, root cause analysis, and risk mitigation.

• Drive a culture of continuous improvement, innovation and talent development, supporting team members to maximize impact in a current role and prepare for future roles within AZ.

• Author protocols, development reports, finished product specifications, tech transfer, and design control documents.

• Author sections of regulatory documents (e.g., NDAs, INDs, Briefing Documents, etc.) as combination product development subject matter expert (SME). Meets project deadlines for the US and ROW submissions.

• Organize and interpret large data sets and communicate data impact or value to senior R&D leadership.

• Participate in design control activities for inhalation drug-device combination product development in order to maintain compliance with 21 CFR 820.30.

Essentials:

• Degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a similar applicable field.

• Ph.D. – 0+ years, MS – 4+ years, BS – 8+ years of relevant industry experience.

• SME on inhalation (MDI, DPI) drug-device combination product development with a working knowledge of inhalation analytical methods and manufacturing processes.

• Familiar with ICH guidelines, USP/EP requirements, and FDA/EU guidance on inhalation dosage forms and drug-device combination and design controls.

• Working experience in a GMP environment.

• Solid understanding of JMP, and Microsoft Word, PowerPoint, Excel, and Outlook.

• Knowledge of statistical analysis tools, especially experimental design and interpretation and multivariate analysis of complex data sets.

• Strong analytical problem-solving skills and attention to detail.

• Ability to operate a PC and sit and stand for extended periods of time.

Desired:

• Lean experience desired.

• Experience authoring IND/IMPD/NDA/MAA regulatory filings is desired.

As part of the application process for some roles at AstraZeneca, candidates may be asked to complete a series of online games, created by pymetrics, to assess certain candidate qualities to help evaluate potential match for the position. If the pymetrics process applies to this role, you will receive an email invitation with additional information following application. Once completed AZ will automatically receive your results - pymetrics will not be used solely in our decision-making process but will help us gather additional insight.

Why AstraZeneca?

At AstraZeneca 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 recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods, and bringing unexpected teams together. Interested? Come and join our journey.

Next Steps – Apply today!

Are you ready to bring new ideas and fresh thinking to the table? We have one seat available, and we hope it’s yours. Curious to know more, then please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well-qualified for this opportunity. Know someone who would be a phenomenal fit, please share this posting with them.

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• About Operations: https://www.youtube.com/watch?v=gak5Ham8oUw

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.