Apply on Employer Site

AstraZeneca · 15 hours ago

Principal Scientist, Process Analytical Technology Industrialisation

Durham, NC

Full-time

Onsite

Lead/Staff

10+ years exp

AstraZeneca is a global biopharmaceutical company committed to delivering life-changing medicines. The Principal Scientist will drive the design, development, and validation of enhanced control strategies in commercial manufacturing, focusing on process analytical technology and collaboration with cross-functional teams.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Set clear directions for the organization in areas of analytical sciences like in process analytical technology (PAT)

Support the development and implementation of enhanced control strategies on projects

Advise others at a high level and strengthen presence at commercial manufacturing sites

Drive strategy in the design, development, and validation of high-quality enhanced control strategies

Collaborate with cross-functional teams and contribute to regulatory documentation

Lead projects implementing innovative monitoring and control tools to commercial manufacturing platforms globally

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

Deliver digitally oriented approaches, data science, predictive modelling and simulation, and artificial intelligence

Qualification

Process Analytical TechnologyAdvanced Process ControlPharmaceutical Process EquipmentChemometricsQuality by DesignRegulatory DocumentationData SciencePredictive ModellingArtificial IntelligenceLeadership

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)