Senior Scientist - Process Analytical Technology - APICOM

SeniorScientist -ProcessAnalyticalTechnology-APICOM (Active Pharmaceutical Ingredient Commercialisation)

Location Dublin

Competitive salary and benefits

Join the team where everyone feels a personal connection to the people that weimpact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality.It’sinspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. Toultimately makepeople’s lives better – from patients and their families to all of us in society!

AstraZeneca is a global, innovation-driven biopharmaceutical company where we focus on the discovery,developmentand delivery of life-saving medicines to our patients in addition to our belief in sustainability and determination to minimise the impact of our work on the environment. We are proud to bea great placeto work and have a culture that inspires innovation and collaboration. We empower our colleagues to express diverse perspectives and at the same time feel valued,respectedand rewarded for their ideas and creativity.

We have an exciting opportunity for anexperienced, highly motivated Process Analytical Technology (PAT) Scientist to jointheProcess Technology Groupbasedatan API Commercialisation Facility (APICOM) being constructed in Dublin. Thisgroup willensurethe safe andtimelyintroduction and manufacture of late-stage clinical and commercial API (Active Pharmaceutical Ingredients). Thisstate-of-the-artfacility includes the latest manufacturing and digital technologies to support autonomous batch and continuous manufacturing

As an experiencedProcess Analytical Technologyscientist with aprovenrecord ofdeveloping,transferringand implementingPATsolutions forpharmaceuticaldrugsubstance manufacturing,you willbe responsible forleading the use of PATas an enhanced control strategy solutionin a modern,state-of-the-artmanufacturingfacility.  

In this role,the successful applicantwill provide PAT leadershipandexpertisewhilst collaborating with colleagues from Chemical Development(Macclesfield, UK)totransfer PAT methods from the lab tothe APICOMFacilityin Dublin.  Theywillalsowork collaboratively within multiskilled groupswithinAPICOM,including analytical, chemistry,chemical engineering,plantengineersand plant operators. The role willrequireproactiveplanningandcoordination with multiplecustomersto ensure successful andtimelyimplementation of PAT inpreparation for a manufacturing campaign.

Key Responsibilities:

• Leadthe introductionofseveral PAT instruments, ensuring thatthey aremaintainedand operatedin accordance withcGMP.

• Implement Standard Operating Procedures or other guidance documents for the safeand effectiveuse of PAT within APICOM.

• Take ownership of critical business processesrelated tothe transfer and utilisation of PAT methods and associated chemometric models, ensuring alignment with industry standards and regulatory requirements.Represent the department as a Subject Matter Expert (SME) during internal and external audits, providing insights and guidance onProcessAnalyticalTechnology.

• Coordinate withChemical Developmentproject teams and localaccommodationteamstoreviewmanufacturingschedulesandensure availabilityand readinessof key equipment.

• Receive training and developexperienceas aSiemens SIPAT superuser, providing localexpertsupport for theconfiguration and deployment of SIPAT methodsfor manufacturing campaigns.

• Represent APICOM on the AstraZenecaglobal Siemens SIPAT user groups.

• Demonstrate scientific leadership and strategic development of PAT capability within APICOMby driving continual improvementsand sharing learningwithin APICOM/Chemical Developmentand wider PATnetworks within AZ.

• Build PATcapability andexperience within APICOMthrough the training and coaching of colleagues.

Essential requirements:

• Bachelorsdegree orPhD level education inchemistry, analyticalchemistryor chemical engineeringwith experienceofworking within a Research & Development and/orManufacturing environment.

• A strong understanding and provenrecordforthe development and delivery of drug substance control strategies using PAT.

• Significant practical experienceusing severalofthemajor PATspectroscopictechniquesincludingnear-IR,mid-IR,Raman,UV/VisandFBRMineitheralaboratoryor GMPmanufacturingenvironment. 

• A strong data-centric mindset with proven abilityin the area ofchemometrics

• A thorough understanding of the principles and management of SHE and cGMPfordrug substance manufacturing.

Preferred Requirements:

• Experience of managing change within a regulated manufacturing environment.

• Experience indeveloping,validatingandtransferringquantitativemultivariatemodelsforreal-time PAT monitoring of drug substance unit operations

• Strong coding skills,preferably in MATLABorPython

• Practical experienceofusing a PAT data management system, such asSiemens SIPAT in a development or manufacturingenvironment.

• Experience of technical supervision,coachingand mentoring.

• Experience ofintroducingnew analytical technologies, includingdefining user requirements,providingtrainingandestablishingstandard operating procedures.

Why AstraZeneca

At AstraZeneca,we’rededicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.There’sno better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development!

SoWhat's Next

Are you already imagining yourself joining our team? Good, because wecan’twait to hear from you.

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