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AstraZeneca · 2 months ago

Principal Scientist, Process Analytical Technology Industrialisation

US - Durham - NC

Full-time

Onsite

Lead/Staff

10+ years exp

AstraZeneca is a global biopharmaceutical company focused on delivering life-changing medicines. The Principal Scientist in Process Analytical Technology will drive the design, development, and validation of enhanced control strategies in commercial manufacturing settings, collaborating with cross-functional teams to implement innovative monitoring and control tools globally.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Play a crucial role in driving our strategy in the design, development, and validation of high-quality enhanced control strategies by applying your expert knowledge in the areas of PAT, Chemometrics, advanced process monitoring and control tools, quality systems and global regulations

Collaborate with cross-functional teams, contribute to regulatory documentation, and lead projects implementing innovative monitoring and control tools to our commercial manufacturing platforms globally, with a strong focus on continuous manufacturing

Drive standards and apply Lean in the validation and technical transfer of models and/ or PAT tools supporting product control strategies across Operations

Bring a future focussed, innovative mindset to deliver further digitally oriented approaches, data science, predictive modelling and simulation, and artificial intelligence

Qualification

Process Analytical TechnologyChemometricsAdvanced process controlQuality by DesignPharmaceutical process equipmentGMP complianceData integritySafetyHealth & EnvironmentScientific excellenceLeadership

Required

Master's degree

Minimum of 10 years industrial experience (Analytical Chemistry, Pharmaceutical Sciences, or Engineering)

Demonstrated delivery in PAT, advanced process control or model predictive control in late phase/ early commercial pharmaceutical manufacturing including technology transfer

Well versed in ICH guidelines (Q2, Q8, Q9, Q10, Q13 and Q14), Quality by Design principles, development and implementation of enhanced approaches for project/product specific control strategies

Experience in authoring relevant sections of NDA/MAA and defence, support of PPQ/CPV, and PAI

Expert knowledge of pharmaceutical process equipment/technology for continuous processes

Demonstrated experience of ensuring compliance with operational requirements (GMP, GAMP, Process Safety, Data integrity, Change Control)

An understanding of the principles and management of Safety, Health & Environment (SHE)

Preferred

PhD Degree

Experience of working with contract manufacturing organisations to deliver effective PAT solutions

Track record of scientific excellence and externally recognized expertise in PAT with a strong and sustained publication record in this area, for example publications, patents, conference presentations

Demonstrated leadership with direct or matrix management of highly skilled scientists

Experience in the deployment of PAT in manufacturing technologies for multiple formulation deliveries (e.g. oral, inhaled or injectables)

Knowledge of PAT application in development or manufacturing of combination products is highly desirable

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)